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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00391872




Registration number
NCT00391872
Ethics application status
Date submitted
23/10/2006
Date registered
25/10/2006
Date last updated
13/03/2012

Titles & IDs
Public title
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Scientific title
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Secondary ID [1] 0 0
PLATO
Secondary ID [2] 0 0
D5130C05262
Universal Trial Number (UTN)
Trial acronym
PLATO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Clopidogrel

Active comparator: Clopidogrel - Oral treatment

Experimental: Ticagrelor - Oral treatment


Treatment: Drugs: Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Treatment: Drugs: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Timepoint [1] 0 0
Randomization up to 12 months
Primary outcome [2] 0 0
Participants With Any Major Bleeding Event
Timepoint [2] 0 0
First dosing up to 12 months
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Timepoint [1] 0 0
Randomization up to 12 months
Secondary outcome [2] 0 0
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Timepoint [2] 0 0
Randomization up to 12 months
Secondary outcome [3] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Timepoint [3] 0 0
Randomization up to 12 months
Secondary outcome [4] 0 0
Participants With MI Event
Timepoint [4] 0 0
Randomization up to 12 months
Secondary outcome [5] 0 0
Participants With Death From Vascular Causes
Timepoint [5] 0 0
Randomization up to 12 months
Secondary outcome [6] 0 0
Participants With Stroke
Timepoint [6] 0 0
Randomization up to 12 months
Secondary outcome [7] 0 0
Participants With Death From Any Cause
Timepoint [7] 0 0
Randomization up to 12 months
Secondary outcome [8] 0 0
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Timepoint [8] 0 0
First dosing up to 12 months
Secondary outcome [9] 0 0
Participants With Major or Minor Bleeding
Timepoint [9] 0 0
First dosing up to 12 months
Secondary outcome [10] 0 0
Participants With Non-procedural Major Bleeding
Timepoint [10] 0 0
First dosing up to 12 months
Secondary outcome [11] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Timepoint [11] 0 0
First dosing up to 12 months
Secondary outcome [12] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Timepoint [12] 0 0
First dosing up to 12 months
Secondary outcome [13] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Timepoint [13] 0 0
1-week period following randomization
Secondary outcome [14] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Timepoint [14] 0 0
1-week period following randomization

Eligibility
Key inclusion criteria
* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
18624
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Bruce
Recruitment hospital [2] 0 0
Research Site - Chermside
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Research Site - Herston
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Research Site - Woolloongabba
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Research Site - Bedford Park
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Research Site - Melbourne
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Research Site - Perth
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- Dandenong
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- Geelong
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- Melbourne
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- Perth
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Germany
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Germany
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Germany
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Germany
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Germany
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Muhlheim An Der Ruhr
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Germany
State/province [223] 0 0
Munster
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Germany
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Germany
State/province [225] 0 0
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Germany
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ULM
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Germany
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Warendorf
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Germany
State/province [228] 0 0
Witten
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Germany
State/province [229] 0 0
Wuppertal
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Germany
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Greece
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Crete
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Greece
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Athens
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Larissa
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Greece
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Patra
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Greece
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Piraeus
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Greece
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Cegled
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Hodmez-vasarhely
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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India
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India
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Delhi
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India
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Gujarat
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India
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Karnataka
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India
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Kerala
Country [254] 0 0
India
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Madhya Pradesh
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India
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Maharashtra
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India
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Punjab
Country [257] 0 0
India
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Rajasthan
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India
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Tamilnadu
Country [259] 0 0
India
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West Bengal
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Bali
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Indonesia
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Jawa Barat
Country [262] 0 0
Indonesia
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Jawa Timur
Country [263] 0 0
Indonesia
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Jakarta
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Indonesia
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Makassar
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Indonesia
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Semarang
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Israel
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Afula
Country [267] 0 0
Israel
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Ashkelon
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Israel
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Israel
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Hadera
Country [270] 0 0
Israel
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Haifa
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Israel
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Israel
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Jerusalem
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Israel
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Poriya M.p. Lower Galilee
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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AN
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BA
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BG
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CE
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CT
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SS
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VE
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VR
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Massa Carrara
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Italy
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Wilayah Persekutuan
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Mexico
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Mexico
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Mexico
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Mexico
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Netherlands
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Netherlands
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Netherlands
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Philippines
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Poland
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Poland
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Bydgoszcz
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Poland
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Bytom
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Poland
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Poland
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Elblag
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Poland
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Grodzisk Mazowiecki
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Plock
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Poland
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Radom
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Poland
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Poland
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Tarnow
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Poland
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Torun
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Poland
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Walbrzych
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Poland
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Poland
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Poland
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Wloclawek
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Poland
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Wroclaw
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Poland
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Portugal
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Aveiro
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Leiria
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Portugal
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Lisboa
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Portugal
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Portugal
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Santa Maria Da Feira
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Portugal
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Portugal
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Country [411] 0 0
Portugal
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Portugal
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Vila Real
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San Juan
Country [414] 0 0
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Romania
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Cluj
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Romania
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Braila
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Romania
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Brasov
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Romania
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Romania
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Romania
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Romania
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Iasi
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Romania
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Suceava
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Russian Federation
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Khanty-mansiysk Autonomous Dis
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Russian Federation
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Barnaul
Country [425] 0 0
Russian Federation
State/province [425] 0 0
Ekaterinburg
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Russian Federation
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Irkutsk
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Russian Federation
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Kaliningrad
Country [428] 0 0
Russian Federation
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Kazan
Country [429] 0 0
Russian Federation
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Kemerovo
Country [430] 0 0
Russian Federation
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Krasnodar
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Murmansk
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-na-donu
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Singapore
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Singapore
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Liptovsky Mikulas
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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Slovakia
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Piestany
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Slovakia
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Ruzomberok
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Slovakia
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Trnava
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Slovakia
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Cape Town
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South Africa
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Free State
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Pretoria
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Spain
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Spain
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Spain
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Cataluna
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Spain
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Comunidad de Madrid
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Spain
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Comunidad Valenciana
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Spain
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Spain
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Spain
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Islas Baleares
Country [464] 0 0
Sweden
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Boras
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Sweden
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Eksjo
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Sweden
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Eskilstuna
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Sweden
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Falun
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Sweden
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Halmstad
Country [469] 0 0
Sweden
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Jonkoping
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Sweden
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Country [471] 0 0
Sweden
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Sweden
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Lidkoping
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Sweden
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Linkoping
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Sweden
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Sweden
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Lund
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Sweden
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Sweden
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Country [478] 0 0
Sweden
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Stockholm
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Sweden
State/province [479] 0 0
Sundsvall
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Sweden
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Uppsala
Country [481] 0 0
Sweden
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Vasteras
Country [482] 0 0
Switzerland
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Country [483] 0 0
Switzerland
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Bellinzona
Country [484] 0 0
Switzerland
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Bern
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Switzerland
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Switzerland
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Switzerland
State/province [487] 0 0
Lugano
Country [488] 0 0
Taiwan
State/province [488] 0 0
Kaohsiung
Country [489] 0 0
Taiwan
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Taoyuan Hsien
Country [490] 0 0
Taiwan
State/province [490] 0 0
Taipei
Country [491] 0 0
Thailand
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Bangkok
Country [492] 0 0
Thailand
State/province [492] 0 0
Chiang Mai
Country [493] 0 0
Thailand
State/province [493] 0 0
Khon Kaen
Country [494] 0 0
Turkey
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Kartal
Country [495] 0 0
Turkey
State/province [495] 0 0
Sihhiye
Country [496] 0 0
Turkey
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Adana
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Turkey
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Turkey
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Mersin
Country [499] 0 0
Ukraine
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Ukraine
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Donetsk
Country [501] 0 0
Ukraine
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Kharkov
Country [502] 0 0
Ukraine
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Kiev
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Ukraine
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Country [504] 0 0
United Kingdom
State/province [504] 0 0
Lanarkshire
Country [505] 0 0
United Kingdom
State/province [505] 0 0
Northern Ireland
Country [506] 0 0
United Kingdom
State/province [506] 0 0
Basingstoke
Country [507] 0 0
United Kingdom
State/province [507] 0 0
Birmingham
Country [508] 0 0
United Kingdom
State/province [508] 0 0
Blackpool
Country [509] 0 0
United Kingdom
State/province [509] 0 0
Dundee
Country [510] 0 0
United Kingdom
State/province [510] 0 0
Edinburgh
Country [511] 0 0
United Kingdom
State/province [511] 0 0
Glasgow
Country [512] 0 0
United Kingdom
State/province [512] 0 0
Leicester
Country [513] 0 0
United Kingdom
State/province [513] 0 0
London
Country [514] 0 0
United Kingdom
State/province [514] 0 0
Manchester
Country [515] 0 0
United Kingdom
State/province [515] 0 0
Middlesborough
Country [516] 0 0
United Kingdom
State/province [516] 0 0
Poole
Country [517] 0 0
United Kingdom
State/province [517] 0 0
Sheffield
Country [518] 0 0
United Kingdom
State/province [518] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.
Trial website
https://clinicaltrials.gov/study/NCT00391872
Trial related presentations / publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Samman KN, Mehanna P, Takla E, Grenier JC, Chan MY, Lopes RD, Neely ML, Wang TY, Newby LK, Becker RC, Lordkipanidze M, Ruiz M, Hussin JG, Jolicoeur EM. Differential modulation of polyunsaturated fatty acids in patients with myocardial infarction treated with ticagrelor or clopidogrel. Cell Rep Med. 2021 Jun 4;2(6):100299. doi: 10.1016/j.xcrm.2021.100299. eCollection 2021 Jun 15.
Thi Thu Nguyen T, Van Do D, Mellstrom C, Quang Nguyen T, Manh Pham H, Van Hoang S, Cong Luu T, Le Phuong T. Cost-Effectiveness of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome from Vietnamese Healthcare Payers' Perspective. Adv Ther. 2021 Jul;38(7):4026-4039. doi: 10.1007/s12325-021-01743-5. Epub 2021 Jun 11.
Mahmoodi BK, Eriksson N, Vos GJA, Meijer K, Siegbahn A, James S, Wallentin L, Ten Berg JM. Factor V Leiden Does Not Modify the Phenotype of Acute Coronary Syndrome or the Extent of Myocardial Necrosis. J Am Heart Assoc. 2021 Jun;10(11):e020025. doi: 10.1161/JAHA.120.020025. Epub 2021 May 17.
Gregersen I, Michelsen AE, Lunde NN, Akerblom A, Lakic TG, Skjelland M, Ryeng Skagen K, Becker RC, Lindback J, Himmelmann A, Solberg R, Johansen HT, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Ueland T, Wallentin L, Halvorsen B. Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2020 Sep;9(17):e016360. doi: 10.1161/JAHA.120.016360. Epub 2020 Aug 15.
Sumaya W, Wallentin L, James SK, Siegbahn A, Gabrysch K, Himmelmann A, Ajjan RA, Storey RF. Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome Patients with Diabetes: A PLATO Sub-Study. Thromb Haemost. 2020 Mar;120(3):412-422. doi: 10.1055/s-0039-1701011. Epub 2020 Jan 23.
Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Becker RC, Bertilsson M, Budaj A, Cornel JH, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Wallentin L; PLATO Investigators. ALCAM predicts future cardiovascular death in acute coronary syndromes: Insights from the PLATO trial. Atherosclerosis. 2020 Jan;293:35-41. doi: 10.1016/j.atherosclerosis.2019.11.031. Epub 2019 Nov 29.
Andersen T, Ueland T, Ghukasyan Lakic T, Akerblom A, Bertilsson M, Aukrust P, Michelsen AE, James SK, Becker RC, Storey RF, Wallentin L, Siegbahn A, Kontny F. C-X-C Ligand 16 Is an Independent Predictor of Cardiovascular Death and Morbidity in Acute Coronary Syndromes. Arterioscler Thromb Vasc Biol. 2019 Nov;39(11):2402-2410. doi: 10.1161/ATVBAHA.119.312633. Epub 2019 Sep 26.
Akerblom A, Wojdyla DM, Wallentin L, James SK, de Souza Brito F, Steg PG, Cannon CP, Katus HA, Himmelmann A, Storey RF, Becker RC, Lopes RD; PLATO Investigators. Ticagrelor in patients with heart failure after acute coronary syndromes-Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2019 Jul;213:57-65. doi: 10.1016/j.ahj.2019.04.006. Epub 2019 Apr 18.
Franchi F, James SK, Ghukasyan Lakic T, Budaj AJ, Cornel JH, Katus HA, Keltai M, Kontny F, Lewis BS, Storey RF, Himmelmann A, Wallentin L, Angiolillo DJ; PLATO Investigators. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial. J Am Heart Assoc. 2019 Mar 19;8(6):e011139. doi: 10.1161/JAHA.118.011139.
Lindholm D, James SK, Gabrysch K, Storey RF, Himmelmann A, Cannon CP, Mahaffey KW, Steg PG, Held C, Siegbahn A, Wallentin L. Association of Multiple Biomarkers With Risk of All-Cause and Cause-Specific Mortality After Acute Coronary Syndromes: A Secondary Analysis of the PLATO Biomarker Study. JAMA Cardiol. 2018 Dec 1;3(12):1160-1166. doi: 10.1001/jamacardio.2018.3811.
Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Aukrust P, Becker RC, Bertilsson M, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Wallentin L; PLATO (Platelet Inhibition and Patient Outcomes) Trial Investigators. Osteoprotegerin Is Associated With Major Bleeding But Not With Cardiovascular Outcomes in Patients With Acute Coronary Syndromes: Insights From the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2018 Jan 12;7(2):e007009. doi: 10.1161/JAHA.117.007009.
Bellavia A, Wallentin L, Orsini N, James SK, Cannon CP, Himmelmann A, Sundstrom J, Renlund H, Lytsy P. Time-based measures of treatment effect: reassessment of ticagrelor and clopidogrel from the PLATO trial. Open Heart. 2017 Jun 1;4(2):e000557. doi: 10.1136/openhrt-2016-000557. eCollection 2017.
Lindholm D, Hagstrom E, James SK, Becker RC, Cannon CP, Himmelmann A, Katus HA, Maurer G, Lopez-Sendon JL, Steg PG, Storey RF, Siegbahn A, Wallentin L. Growth Differentiation Factor 15 at 1 Month After an Acute Coronary Syndrome Is Associated With Increased Risk of Major Bleeding. J Am Heart Assoc. 2017 Apr 14;6(4):e005580. doi: 10.1161/JAHA.117.005580.
Lindholm D, James SK, Bertilsson M, Becker RC, Cannon CP, Giannitsis E, Harrington RA, Himmelmann A, Kontny F, Siegbahn A, Steg PG, Storey RF, Velders MA, Weaver WD, Wallentin L; PLATO Investigators. Biomarkers and Coronary Lesions Predict Outcomes after Revascularization in Non-ST-Elevation Acute Coronary Syndrome. Clin Chem. 2017 Feb;63(2):573-584. doi: 10.1373/clinchem.2016.261271. Epub 2016 Dec 8.
Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
Johansson A, Eriksson N, Lindholm D, Varenhorst C, James S, Syvanen AC, Axelsson T, Siegbahn A, Barratt BJ, Becker RC, Himmelmann A, Katus HA, Steg PG, Storey RF, Wallentin L; PLATO Investigators. Genome-wide association and Mendelian randomization study of NT-proBNP in patients with acute coronary syndrome. Hum Mol Genet. 2016 Apr 1;25(7):1447-56. doi: 10.1093/hmg/ddw012. Epub 2016 Jan 21.
Velders MA, Abtan J, Angiolillo DJ, Ardissino D, Harrington RA, Hellkamp A, Himmelmann A, Husted S, Katus HA, Meier B, Schulte PJ, Storey RF, Wallentin L, Gabriel Steg P, James SK; PLATO Investigators. Safety and efficacy of ticagrelor and clopidogrel in primary percutaneous coronary intervention. Heart. 2016 Apr;102(8):617-25. doi: 10.1136/heartjnl-2015-308963. Epub 2016 Feb 4.
Bui AH, Cannon CP, Steg PG, Storey RF, Husted S, Guo J, Im K, James SK, Michelson EL, Himmelmann A, Held C, Varenhorst C, Wallentin L, Scirica BM. Relationship Between Early and Late Nonsustained Ventricular Tachycardia and Cardiovascular Death in Patients With Acute Coronary Syndrome in the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e002951. doi: 10.1161/CIRCEP.115.002951.
Andell P, James SK, Cannon CP, Cyr DD, Himmelmann A, Husted S, Keltai M, Koul S, Santoso A, Steg PG, Storey RF, Wallentin L, Erlinge D; PLATO Investigators. Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes and Chronic Obstructive Pulmonary Disease: An Analysis From the Platelet Inhibition and Patient Outcomes (PLATO) Trial. J Am Heart Assoc. 2015 Oct 9;4(10):e002490. doi: 10.1161/JAHA.115.002490.
Hagstrom E, James SK, Bertilsson M, Becker RC, Himmelmann A, Husted S, Katus HA, Steg PG, Storey RF, Siegbahn A, Wallentin L; PLATO Investigators. Growth differentiation factor-15 level predicts major bleeding and cardiovascular events in patients with acute coronary syndromes: results from the PLATO study. Eur Heart J. 2016 Apr 21;37(16):1325-33. doi: 10.1093/eurheartj/ehv491. Epub 2015 Sep 28.
Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.
Kang HJ, Clare RM, Gao R, Held C, Himmelmann A, James SK, Lim ST, Santoso A, Yu CM, Wallentin L, Becker RC; PLATO Investigators. Ticagrelor versus clopidogrel in Asian patients with acute coronary syndrome: A retrospective analysis from the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Am Heart J. 2015 Jun;169(6):899-905.e1. doi: 10.1016/j.ahj.2015.03.015. Epub 2015 Mar 31.
Velders MA, Wallentin L, Becker RC, van Boven AJ, Himmelmann A, Husted S, Katus HA, Lindholm D, Morais J, Siegbahn A, Storey RF, Wernroth L, James SK; PLATO Investigators. Biomarkers for risk stratification of patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention: Insights from the Platelet Inhibition and Patient Outcomes trial. Am Heart J. 2015 Jun;169(6):879-889.e7. doi: 10.1016/j.ahj.2015.02.019. Epub 2015 Mar 5.
Varenhorst C, Eriksson N, Johansson A, Barratt BJ, Hagstrom E, Akerblom A, Syvanen AC, Becker RC, James SK, Katus HA, Husted S, Steg PG, Siegbahn A, Voora D, Teng R, Storey RF, Wallentin L; PLATO Investigators. Effect of genetic variations on ticagrelor plasma levels and clinical outcomes. Eur Heart J. 2015 Aug 1;36(29):1901-12. doi: 10.1093/eurheartj/ehv116. Epub 2015 May 2.
Kholaif N, Zheng Y, Jagasia P, Himmelmann A, James SK, Steg PG, Storey RF, Westerhout CM, Armstrong PW. Baseline Q waves and time from symptom onset to ST-segment elevation myocardial infarction: insights from PLATO on the influence of sex. Am J Med. 2015 Aug;128(8):914.e11-9. doi: 10.1016/j.amjmed.2015.03.005. Epub 2015 Mar 26.
Cowper PA, Pan W, Anstrom KJ, Kaul P, Wallentin L, Davidson-Ray L, Nikolic E, Janzon M, Levin LA, Cannon CP, Harrington RA, Mark DB. Economic analysis of ticagrelor therapy from a U.S. perspective: results from the PLATO study. J Am Coll Cardiol. 2015 Feb 10;65(5):465-76. doi: 10.1016/j.jacc.2014.11.034.
Janzon M, James S, Cannon CP, Storey RF, Mellstrom C, Nicolau JC, Wallentin L, Henriksson M. Health economic analysis of ticagrelor in patients with acute coronary syndromes intended for non-invasive therapy. Heart. 2015 Jan;101(2):119-25. doi: 10.1136/heartjnl-2014-305864. Epub 2014 Sep 16.
Varenhorst C, Alstrom U, Braun OO, Storey RF, Mahaffey KW, Bertilsson M, Cannon CP, Scirica BM, Himmelmann A, James SK, Wallentin L, Held C. Causes of mortality with ticagrelor compared with clopidogrel in acute coronary syndromes. Heart. 2014 Nov;100(22):1762-9. doi: 10.1136/heartjnl-2014-305619. Epub 2014 Jun 23.
Kotsia A, Brilakis ES, Held C, Cannon C, Steg GP, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, James SK. Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2014 Jul;168(1):68-75.e2. doi: 10.1016/j.ahj.2014.04.001. Epub 2014 Apr 13.
Patel MR, Becker RC, Wojdyla DM, Emanuelsson H, Hiatt WR, Horrow J, Husted S, Mahaffey KW, Steg PG, Storey RF, Wallentin L, James SK. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared with clopidogrel: Data from the PLATO Trial. Eur J Prev Cardiol. 2015 Jun;22(6):734-42. doi: 10.1177/2047487314533215. Epub 2014 May 15.
Husted S, James SK, Bach RG, Becker RC, Budaj A, Heras M, Himmelmann A, Horrow J, Katus HA, Lassila R, Morais J, Nicolau JC, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATO study group. The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial. Eur Heart J. 2014 Jun 14;35(23):1541-50. doi: 10.1093/eurheartj/ehu075. Epub 2014 Mar 28.
Mahaffey KW, Held C, Wojdyla DM, James SK, Katus HA, Husted S, Steg PG, Cannon CP, Becker RC, Storey RF, Khurmi NS, Nicolau JC, Yu CM, Ardissino D, Budaj A, Morais J, Montgomery D, Himmelmann A, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol. 2014 Apr 22;63(15):1493-9. doi: 10.1016/j.jacc.2014.01.038. Epub 2014 Feb 19.
Wallentin L, Lindholm D, Siegbahn A, Wernroth L, Becker RC, Cannon CP, Cornel JH, Himmelmann A, Giannitsis E, Harrington RA, Held C, Husted S, Katus HA, Mahaffey KW, Steg PG, Storey RF, James SK; PLATO study group. Biomarkers in relation to the effects of ticagrelor in comparison with clopidogrel in non-ST-elevation acute coronary syndrome patients managed with or without in-hospital revascularization: a substudy from the Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2014 Jan 21;129(3):293-303. doi: 10.1161/CIRCULATIONAHA.113.004420. Epub 2013 Oct 29.
Brilakis ES, Held C, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, James SK. Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the PLATelet inhibition and patient outcomes (PLATO) trial. Am Heart J. 2013 Sep;166(3):474-80. doi: 10.1016/j.ahj.2013.06.019. Epub 2013 Jul 26.
Steg PG, Harrington RA, Emanuelsson H, Katus HA, Mahaffey KW, Meier B, Storey RF, Wojdyla DM, Lewis BS, Maurer G, Wallentin L, James SK; PLATO Study Group. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial. Circulation. 2013 Sep 3;128(10):1055-65. doi: 10.1161/CIRCULATIONAHA.113.002589. Epub 2013 Jul 30.
Kunadian V, James SK, Wojdyla DM, Zorkun C, Wu J, Storey RF, Steg PG, Katus H, Emanuelsson H, Horrow J, Maya J, Wallentin L, Harrington RA, Gibson CM. Angiographic outcomes in the PLATO Trial (Platelet Inhibition and Patient Outcomes). JACC Cardiovasc Interv. 2013 Jul;6(7):671-83. doi: 10.1016/j.jcin.2013.03.014.
James SK, Storey RF, Pieper KS, Cannon CP, Becker RC, Steg PG, Wallentin L, Harrington RA; PLATO Study Group. Response to letter regarding article, "Ticagrelor in patients with acute coronary syndromes and stroke: interpretation of subgroups in clinical trials". Stroke. 2013 Aug;44(8):e95-6. doi: 10.1161/STROKEAHA.113.002069. Epub 2013 Jun 25. No abstract available.
James SK, Pieper KS, Cannon CP, Storey RF, Becker RC, Steg PG, Wallentin L, Harrington RA; PLATO study group. Ticagrelor in patients with acute coronary syndromes and stroke: interpretation of subgroups in clinical trials. Stroke. 2013 May;44(5):1477-9. doi: 10.1161/STROKEAHA.111.000514. Epub 2013 Apr 9. No abstract available.
Kohli P, Wallentin L, Reyes E, Horrow J, Husted S, Angiolillo DJ, Ardissino D, Maurer G, Morais J, Nicolau JC, Oto A, Storey RF, James SK, Cannon CP. Reduction in first and recurrent cardiovascular events with ticagrelor compared with clopidogrel in the PLATO Study. Circulation. 2013 Feb 12;127(6):673-80. doi: 10.1161/CIRCULATIONAHA.112.124248. Epub 2012 Dec 31.
Akerblom A, Wallentin L, Siegbahn A, Becker RC, Budaj A, Horrow J, Husted S, Katus H, Claeys MJ, Storey RF, Asenblad N, James SK. Outcome and causes of renal deterioration evaluated by serial cystatin C measurements in acute coronary syndrome patients -- results from the PLATelet inhibition and patient Outcomes (PLATO) study. Am Heart J. 2012 Nov;164(5):728-34. doi: 10.1016/j.ahj.2012.08.017. Epub 2012 Oct 17.
Varenhorst C, Alstrom U, Scirica BM, Hogue CW, Asenblad N, Storey RF, Steg PG, Horrow J, Mahaffey KW, Becker RC, James S, Cannon CP, Brandrup-Wognsen G, Wallentin L, Held C. Factors contributing to the lower mortality with ticagrelor compared with clopidogrel in patients undergoing coronary artery bypass surgery. J Am Coll Cardiol. 2012 Oct 23;60(17):1623-30. doi: 10.1016/j.jacc.2012.07.021. Epub 2012 Sep 26.
Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. doi: 10.1161/CIRCOUTCOMES.111.964395.
Cornel JH, Becker RC, Goodman SG, Husted S, Katus H, Santoso A, Steg G, Storey RF, Vintila M, Sun JL, Horrow J, Wallentin L, Harrington R, James S. Prior smoking status, clinical outcomes, and the comparison of ticagrelor with clopidogrel in acute coronary syndromes-insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2012 Sep;164(3):334-342.e1. doi: 10.1016/j.ahj.2012.06.005. Epub 2012 Jul 26.
Nikolic E, Janzon M, Hauch O, Wallentin L, Henriksson M; PLATO Health Economic Substudy Group. Cost-effectiveness of treating acute coronary syndrome patients with ticagrelor for 12 months: results from the PLATO study. Eur Heart J. 2013 Jan;34(3):220-8. doi: 10.1093/eurheartj/ehs149. Epub 2012 Jun 19.
James SK, Storey RF, Khurmi NS, Husted S, Keltai M, Mahaffey KW, Maya J, Morais J, Lopes RD, Nicolau JC, Pais P, Raev D, Lopez-Sendon JL, Stevens SR, Becker RC; PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes and a history of stroke or transient ischemic attack. Circulation. 2012 Jun 12;125(23):2914-21. doi: 10.1161/CIRCULATIONAHA.111.082727. Epub 2012 May 9.
Siha H, Das D, Fu Y, Zheng Y, Westerhout CM, Storey RF, James S, Wallentin L, Armstrong PW. Baseline Q waves as a prognostic modulator in patients with ST-segment elevation: insights from the PLATO trial. CMAJ. 2012 Jul 10;184(10):1135-42. doi: 10.1503/cmaj.111683. Epub 2012 Apr 30.
Goodman SG, Clare R, Pieper KS, Nicolau JC, Storey RF, Cantor WJ, Mahaffey KW, Angiolillo DJ, Husted S, Cannon CP, James SK, Kilhamn J, Steg PG, Harrington RA, Wallentin L; Platelet Inhibition and Patient Outcomes Trial Investigators. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation. 2012 Feb 28;125(8):978-86. doi: 10.1161/CIRCULATIONAHA.111.032912. Epub 2012 Jan 18.
Armstrong PW, Siha H, Fu Y, Westerhout CM, Steg PG, James SK, Storey RF, Horrow J, Katus H, Clemmensen P, Harrington RA, Wallentin L. ST-elevation acute coronary syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) trial: insights from the ECG substudy. Circulation. 2012 Jan 24;125(3):514-21. doi: 10.1161/CIRCULATIONAHA.111.047530. Epub 2011 Dec 16.
Becker RC, Bassand JP, Budaj A, Wojdyla DM, James SK, Cornel JH, French J, Held C, Horrow J, Husted S, Lopez-Sendon J, Lassila R, Mahaffey KW, Storey RF, Harrington RA, Wallentin L. Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial. Eur Heart J. 2011 Dec;32(23):2933-44. doi: 10.1093/eurheartj/ehr422. Epub 2011 Nov 16. Erratum In: Eur Heart J. 2012 Nov;33(21):2750.
Mahaffey KW, Wojdyla DM, Carroll K, Becker RC, Storey RF, Angiolillo DJ, Held C, Cannon CP, James S, Pieper KS, Horrow J, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2011 Aug 2;124(5):544-54. doi: 10.1161/CIRCULATIONAHA.111.047498. Epub 2011 Jun 27.
James SK, Roe MT, Cannon CP, Cornel JH, Horrow J, Husted S, Katus H, Morais J, Steg PG, Storey RF, Stevens S, Wallentin L, Harrington RA; PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomised PLATelet inhibition and patient Outcomes (PLATO) trial. BMJ. 2011 Jun 17;342:d3527. doi: 10.1136/bmj.d3527.
Scirica BM, Cannon CP, Emanuelsson H, Michelson EL, Harrington RA, Husted S, James S, Katus H, Pais P, Raev D, Spinar J, Steg PG, Storey RF, Wallentin L; PLATO Investigators. The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiographic assessment substudy. J Am Coll Cardiol. 2011 May 10;57(19):1908-16. doi: 10.1016/j.jacc.2010.11.056.
Steg PG, James S, Harrington RA, Ardissino D, Becker RC, Cannon CP, Emanuelsson H, Finkelstein A, Husted S, Katus H, Kilhamn J, Olofsson S, Storey RF, Weaver WD, Wallentin L; PLATO Study Group. Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis. Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8.
James S, Budaj A, Aylward P, Buck KK, Cannon CP, Cornel JH, Harrington RA, Horrow J, Katus H, Keltai M, Lewis BS, Parikh K, Storey RF, Szummer K, Wojdyla D, Wallentin L. Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2010 Sep 14;122(11):1056-67. doi: 10.1161/CIRCULATIONAHA.109.933796. Epub 2010 Aug 30.
Cannon CP, Harrington RA, James S, Ardissino D, Becker RC, Emanuelsson H, Husted S, Katus H, Keltai M, Khurmi NS, Kontny F, Lewis BS, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATelet inhibition and patient Outcomes Investigators. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. Lancet. 2010 Jan 23;375(9711):283-93. doi: 10.1016/S0140-6736(09)62191-7. Epub 2010 Jan 13.
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
Molecule of the month. Ticagrelor. Drug News Perspect. 2007 May;20(4):264. No abstract available.
Public notes

Contacts
Principal investigator
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Robert Harrington, MD
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Duke Clinical Research Institute
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00391872