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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00699998




Registration number
NCT00699998
Ethics application status
Date submitted
16/06/2008
Date registered
18/06/2008
Date last updated
7/05/2013

Titles & IDs
Public title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
Scientific title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
Secondary ID [1] 0 0
H7T-MC-TABY(b)
Secondary ID [2] 0 0
11058
Universal Trial Number (UTN)
Trial acronym
TRILOGY ACS
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 - Clopidogrel
Treatment: Drugs - Prasugrel
Treatment: Drugs - Commercially-available Aspirin

Experimental: Prasugrel - Prasugrel and Low-dose Commercially-available Aspirin

Active comparator: Clopidogrel - Clopidogrel and Low-Dose Commercially-available Aspirin


Treatment: Drugs: Clopidogrel
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Treatment: Drugs: Prasugrel
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study

Treatment: Drugs: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
Timepoint [1] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [1] 0 0
Percentage of Participants With a Composite Endpoint of CV Death and MI
Timepoint [1] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [2] 0 0
Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
Timepoint [2] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [3] 0 0
Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
Timepoint [3] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [4] 0 0
Platelet Aggregation Measures
Timepoint [4] 0 0
Day 30 and 12 Months
Secondary outcome [5] 0 0
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
Timepoint [5] 0 0
Day 30 and 6 Months
Secondary outcome [6] 0 0
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
Timepoint [6] 0 0
Day 30 and Month 6
Secondary outcome [7] 0 0
Genotyping Related to Drug Metabolism
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Economic and Quality of Life Outcomes
Timepoint [8] 0 0
Baseline and follow-up (24 months)
Secondary outcome [9] 0 0
Summary of All Deaths
Timepoint [9] 0 0
Randomization through end of study (30-month visit)

Eligibility
Key inclusion criteria
Key

* Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
* Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
* Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
* Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
* Previous or planned PCI or CABG as treatment for the index event
* PCI/CABG within previous 30 days
* ST-segment elevation myocardial infarction (STEMI) as the index event
* Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
* History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
* History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
* Hemodialysis or peritoneal dialysis

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Coffs Harbour
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Lismore
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Newcastle
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nambour
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Redcliffe
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Southport
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bedford Park
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Recruitment hospital [11] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hobart
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2305 - Newcastle
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4560 - Nambour
Recruitment postcode(s) [7] 0 0
4020 - Redcliffe
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment outside Australia
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France
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France
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France
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France
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France
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Germany
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Germany
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Germany
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Germany
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Halle
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Germany
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Germany
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Germany
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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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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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Ahmedabad
Country [221] 0 0
India
State/province [221] 0 0
Anand
Country [222] 0 0
India
State/province [222] 0 0
Aurangabad
Country [223] 0 0
India
State/province [223] 0 0
Bangalore
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India
State/province [224] 0 0
Baramati
Country [225] 0 0
India
State/province [225] 0 0
Bikaner
Country [226] 0 0
India
State/province [226] 0 0
Calicut
Country [227] 0 0
India
State/province [227] 0 0
Chidambaram
Country [228] 0 0
India
State/province [228] 0 0
Cochin
Country [229] 0 0
India
State/province [229] 0 0
Coimbatore
Country [230] 0 0
India
State/province [230] 0 0
Ernakulam
Country [231] 0 0
India
State/province [231] 0 0
Guntur
Country [232] 0 0
India
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Gurgaon
Country [233] 0 0
India
State/province [233] 0 0
Hyderabaad
Country [234] 0 0
India
State/province [234] 0 0
Indore
Country [235] 0 0
India
State/province [235] 0 0
Jaipur
Country [236] 0 0
India
State/province [236] 0 0
Jalandhar
Country [237] 0 0
India
State/province [237] 0 0
Kolkata
Country [238] 0 0
India
State/province [238] 0 0
Kottayam
Country [239] 0 0
India
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Lucknow
Country [240] 0 0
India
State/province [240] 0 0
Madurai
Country [241] 0 0
India
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Mumbai
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India
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Mysore
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India
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Nagpur
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India
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Nashik
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India
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New Delhi
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India
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Patiala
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India
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Pune
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India
State/province [248] 0 0
Saket
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India
State/province [249] 0 0
Secunderabad
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India
State/province [250] 0 0
Shivamogga
Country [251] 0 0
India
State/province [251] 0 0
Solapur
Country [252] 0 0
India
State/province [252] 0 0
Surat
Country [253] 0 0
India
State/province [253] 0 0
Thrissur
Country [254] 0 0
India
State/province [254] 0 0
Tirupati
Country [255] 0 0
India
State/province [255] 0 0
Trivandrum
Country [256] 0 0
India
State/province [256] 0 0
Vadodara
Country [257] 0 0
India
State/province [257] 0 0
Vijayawada
Country [258] 0 0
India
State/province [258] 0 0
Visakhapatnam
Country [259] 0 0
Ireland
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Dublin
Country [260] 0 0
Ireland
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Galway
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Israel
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Country [262] 0 0
Israel
State/province [262] 0 0
Ashkelon
Country [263] 0 0
Israel
State/province [263] 0 0
Beer Sheva
Country [264] 0 0
Israel
State/province [264] 0 0
Eilat
Country [265] 0 0
Israel
State/province [265] 0 0
Haifa
Country [266] 0 0
Israel
State/province [266] 0 0
Jerusalem
Country [267] 0 0
Israel
State/province [267] 0 0
Kfar Saba
Country [268] 0 0
Israel
State/province [268] 0 0
Nahariya
Country [269] 0 0
Israel
State/province [269] 0 0
Nazareth
Country [270] 0 0
Israel
State/province [270] 0 0
Rehovot
Country [271] 0 0
Israel
State/province [271] 0 0
Tel Aviv
Country [272] 0 0
Israel
State/province [272] 0 0
Tel Hashomer
Country [273] 0 0
Israel
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Tiberias
Country [274] 0 0
Israel
State/province [274] 0 0
Tzfat
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Italy
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Albano Laziale
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Italy
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Ascoli Piceno
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Caserta
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Italy
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Italy
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Italy
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Italy
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Korea, Republic of
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Korea, Republic of
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Jeon Ju-City
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Korea, Republic of
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Korea, Republic of
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Philippines
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Philippines
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Philippines
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Philippines
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Philippines
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Philippines
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Country [371] 0 0
Philippines
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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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Piotrkow Trybunalski
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Poland
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Poland
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Ruda Slaska
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Poland
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Poland
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Portugal
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Portugal
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Portugal
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Puerto Rico
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Puerto Rico
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Pitesti
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Romania
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Romania
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Targoviste
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Russian Federation
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Arkhangelsk
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Russian Federation
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Gatchina
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Russian Federation
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Russian Federation
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Kemerovo
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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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Nizhny Novgorod
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Russian Federation
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Russian Federation
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Russian Federation
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Omsk
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Country [429] 0 0
Russian Federation
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Russian Federation
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Serbia
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Serbia
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Serbia
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Nis
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Serbia
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Slovakia
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Martin
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Slovakia
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Slovakia
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Nove Zamky
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Slovakia
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Slovakia
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Slovakia
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George
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Johannesburg
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Somerset West
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South Africa
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Spain
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Barcelona
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Spain
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Spain
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Spain
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Palma De Mallorca
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Spain
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Reus
Country [459] 0 0
Spain
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San Boi De Llobregat
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Spain
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Spain
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Sweden
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Sweden
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Karlstad
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Sweden
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Lund
Country [465] 0 0
Switzerland
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Switzerland
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Winterthur
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Taiwan
State/province [467] 0 0
Kaohsiung
Country [468] 0 0
Taiwan
State/province [468] 0 0
Taipei
Country [469] 0 0
Thailand
State/province [469] 0 0
Bangkok
Country [470] 0 0
Thailand
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke Clinical Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
Trial website
https://clinicaltrials.gov/study/NCT00699998
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.
Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.
Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31.
Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755.
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.
Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17.
Goldstein SA, Newby LK, Cyr DD, Neely M, Luscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4):e005334. doi: 10.1161/JAHA.116.005334.
Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5.
Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11):e003977. doi: 10.1161/JAHA.116.003977.
Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalan R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30.
Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034.
Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036.
Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalan R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16.
Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5.
Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20.
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.
Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23.
Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10.
Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24. Erratum In: Am Heart J. 2014 Oct;168(4):605.
Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8. Erratum In: Lancet. 2013 Aug 31;382(9894):768.
Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.
Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteza M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.
Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12.
Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022.
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00699998