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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00831441




Registration number
NCT00831441
Ethics application status
Date submitted
28/01/2009
Date registered
29/01/2009
Date last updated
27/01/2016

Titles & IDs
Public title
Phase III Acute Coronary Syndrome
Scientific title
Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome
Secondary ID [1] 0 0
EUDRACT# 2008-008298-77
Secondary ID [2] 0 0
CV185-068
Universal Trial Number (UTN)
Trial acronym
APPRAISE-2
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 - Apixaban
Treatment: Drugs - Placebo

Active comparator: Apixaban -

Placebo comparator: Placebo -


Treatment: Drugs: Apixaban
Tablets, Oral, 5 mg, twice daily, until study end

Treatment: Drugs: Placebo
Tablets, Oral, 0 mg, twice daily, until study end
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [1] 0 0
Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years
Primary outcome [2] 0 0
Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants
Timepoint [2] 0 0
From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcome [1] 0 0
Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants
Timepoint [1] 0 0
Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years
Secondary outcome [2] 0 0
Event Rate of Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [2] 0 0
Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years
Secondary outcome [3] 0 0
Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants
Timepoint [3] 0 0
Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years
Secondary outcome [4] 0 0
Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants
Timepoint [4] 0 0
Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years
Secondary outcome [5] 0 0
Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [5] 0 0
Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years
Secondary outcome [6] 0 0
Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [6] 0 0
Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years
Secondary outcome [7] 0 0
Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [7] 0 0
Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years
Secondary outcome [8] 0 0
Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants
Timepoint [8] 0 0
From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcome [9] 0 0
Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants
Timepoint [9] 0 0
From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcome [10] 0 0
Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants
Timepoint [10] 0 0
From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years

Eligibility
Key inclusion criteria
* Acute coronary syndrome (ACS)
* Clinically stable
* Receiving standard of care for ACS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe hypertension
* Active bleeding or high risk for major bleeding
* Hemoglobin < 9 g/dL

Study design
Purpose of the study
Prevention
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
7484
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Bruce
Recruitment hospital [2] 0 0
Local Institution - Broken Hill
Recruitment hospital [3] 0 0
Local Institution - Kogarah
Recruitment hospital [4] 0 0
Local Institution - Lismore
Recruitment hospital [5] 0 0
Local Institution - Cairns
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Local Institution - Herston
Recruitment hospital [7] 0 0
Local Institution - Milton
Recruitment hospital [8] 0 0
Local Institution - Ashford
Recruitment hospital [9] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [10] 0 0
Local Institution - Woodville
Recruitment hospital [11] 0 0
Local Institution - Fitzroy
Recruitment hospital [12] 0 0
Local Institution - Geelong
Recruitment hospital [13] 0 0
Local Institution - Richmond
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2880 - Broken Hill
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
4031 - Herston
Recruitment postcode(s) [7] 0 0
4064 - Milton
Recruitment postcode(s) [8] 0 0
5035 - Ashford
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
5011 - Woodville
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3121 - Richmond
Recruitment outside Australia
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Szekszard
Country [206] 0 0
Hungary
State/province [206] 0 0
Szentes
Country [207] 0 0
Hungary
State/province [207] 0 0
Szombathely
Country [208] 0 0
Hungary
State/province [208] 0 0
Zalaegerszeg
Country [209] 0 0
India
State/province [209] 0 0
Andhra Pradesh
Country [210] 0 0
India
State/province [210] 0 0
Gujarat
Country [211] 0 0
India
State/province [211] 0 0
Haryana
Country [212] 0 0
India
State/province [212] 0 0
Karnataka
Country [213] 0 0
India
State/province [213] 0 0
Madhya Pradesh
Country [214] 0 0
India
State/province [214] 0 0
Maharashtra
Country [215] 0 0
India
State/province [215] 0 0
Maharastra
Country [216] 0 0
India
State/province [216] 0 0
Punjab
Country [217] 0 0
India
State/province [217] 0 0
Rajasthan
Country [218] 0 0
India
State/province [218] 0 0
Tamil Nadu
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India
State/province [219] 0 0
Tamilnadu
Country [220] 0 0
India
State/province [220] 0 0
Uttar Pradesh
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India
State/province [221] 0 0
Bangalore, Karnataka
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India
State/province [222] 0 0
Bikaner
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India
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Mangalore
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India
State/province [224] 0 0
New Delhi
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India
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Pune
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Israel
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Israel
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Ashkelon
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Israel
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Hadera
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Israel
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Haifa
Country [230] 0 0
Israel
State/province [230] 0 0
Jerusalem
Country [231] 0 0
Israel
State/province [231] 0 0
Kfar-Saba
Country [232] 0 0
Israel
State/province [232] 0 0
Nahariya
Country [233] 0 0
Israel
State/province [233] 0 0
Nazareth
Country [234] 0 0
Israel
State/province [234] 0 0
Petach Tikva
Country [235] 0 0
Israel
State/province [235] 0 0
Rehovot
Country [236] 0 0
Israel
State/province [236] 0 0
Safed
Country [237] 0 0
Israel
State/province [237] 0 0
Tel Aviv
Country [238] 0 0
Israel
State/province [238] 0 0
Tiberias
Country [239] 0 0
Italy
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Ascoli Piceno
Country [240] 0 0
Italy
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Bergamo
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Italy
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Chieti
Country [242] 0 0
Italy
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Foggia
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Italy
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Gravedona (Co)
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Italy
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Grosseto
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Italy
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Massa
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Italy
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Milano
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Italy
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Milan
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Italy
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Naples
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Italy
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Novara
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Italy
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Pavia
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Italy
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Perugia
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Italy
State/province [252] 0 0
Roma
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Italy
State/province [253] 0 0
San Daniele Del Friuli (Udine)
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Italy
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Saronno (Va)
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Italy
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Verona
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Japan
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Aichi
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Japan
State/province [257] 0 0
Chiba
Country [258] 0 0
Japan
State/province [258] 0 0
Fukuoka
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Japan
State/province [259] 0 0
Gifu
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Japan
State/province [260] 0 0
Hiroshima
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Kagoshima
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Japan
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Japan
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Japan
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Oita
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Japan
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Japan
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Saga
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Japan
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Japan
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Tokushima
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Japan
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Tokyo
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Japan
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Japan
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Kochi
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Japan
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Japan
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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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Gwangju
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
State/province [286] 0 0
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Korea, Republic of
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Korea, Republic of
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Mexico
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Mexico
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Baja California
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Mexico
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Mexico
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Mexico
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Mexico
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Hidalgo
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Mexico
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Jalisco
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Mexico
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Mexico
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Mexico
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Mexico
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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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Den Haag
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Dirksland
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Sneek
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Netherlands
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Veldhoven
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Netherlands
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Hastings
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Bergen
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Norway
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Bodo
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Norway
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Drammen
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Norway
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Norway
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Kongsvinger
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Norway
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Norway
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Lillehammer
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Callao
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Lambayeque
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Peru
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Peru
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Peru
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Poland
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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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Gdynia
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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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Kielce
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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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Opole
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Plock
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Poland
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Poland
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Radom
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Poland
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Poland
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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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Poland
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Poland
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Wloclawek
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Poland
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Poland
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Cidra
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Puerto Rico
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Arad
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Romania
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Baia Mare
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Romania
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Braila
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Romania
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Bucharest
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Romania
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Romania
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Oradea
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Romania
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Pitesti
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Romania
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Sibiu
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Romania
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Targu Mures
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Romania
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Timisoara
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kaluga
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
Country [390] 0 0
Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow Reg. Zhekeznodorozhniy
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Russian Federation
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Moscow
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Russian Federation
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Nizhni Novgorod
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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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Odintsovo
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Russian Federation
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Penza
Country [398] 0 0
Russian Federation
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Perm
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Ryazan
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Russian Federation
State/province [401] 0 0
Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
State/province [404] 0 0
St. Petersburg
Country [405] 0 0
Russian Federation
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Tomsk
Country [406] 0 0
Russian Federation
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Tver
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Russian Federation
State/province [407] 0 0
Tyumen
Country [408] 0 0
Russian Federation
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Vasilievsky Island
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Russian Federation
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Voronezh
Country [410] 0 0
Russian Federation
State/province [410] 0 0
Yaroslavl
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Russian Federation
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Zhukovskiy
Country [412] 0 0
Singapore
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Singapore
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Kralovsky Chlmec
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Slovakia
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Liptovsky Hradok
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Slovakia
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Lucenec
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Slovakia
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Martin
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Slovakia
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Nitra
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South Africa
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Eastern Cape
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Kwa Zulu Natal
Country [425] 0 0
South Africa
State/province [425] 0 0
Western Cape
Country [426] 0 0
South Africa
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Country [427] 0 0
Spain
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Alicante
Country [428] 0 0
Spain
State/province [428] 0 0
Asturas
Country [429] 0 0
Spain
State/province [429] 0 0
Gerona
Country [430] 0 0
Spain
State/province [430] 0 0
Madrid
Country [431] 0 0
Spain
State/province [431] 0 0
Almeria
Country [432] 0 0
Spain
State/province [432] 0 0
Barcelona
Country [433] 0 0
Spain
State/province [433] 0 0
Caceres
Country [434] 0 0
Spain
State/province [434] 0 0
El Ejido
Country [435] 0 0
Spain
State/province [435] 0 0
Granada
Country [436] 0 0
Spain
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Lleida
Country [437] 0 0
Spain
State/province [437] 0 0
Lugo
Country [438] 0 0
Spain
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Malaga
Country [439] 0 0
Spain
State/province [439] 0 0
Santiago De Compostela
Country [440] 0 0
Spain
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Country [441] 0 0
Spain
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Tarragona
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Spain
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Torrevieja
Country [443] 0 0
Spain
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Valencia
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Spain
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Valladolid
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Spain
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Zaragoza
Country [446] 0 0
Sweden
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Eskilstuna
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Sweden
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Halmstad
Country [448] 0 0
Sweden
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Helsingborg
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Sweden
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Karlskoga
Country [450] 0 0
Sweden
State/province [450] 0 0
Karlstad
Country [451] 0 0
Sweden
State/province [451] 0 0
Koping
Country [452] 0 0
Sweden
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Lidkoping
Country [453] 0 0
Sweden
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Molndal
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Sweden
State/province [454] 0 0
Skovde
Country [455] 0 0
Sweden
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Stockholm
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Sweden
State/province [456] 0 0
Uppsala
Country [457] 0 0
Sweden
State/province [457] 0 0
Vaxjo
Country [458] 0 0
Switzerland
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Ticino
Country [459] 0 0
Switzerland
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Geneve
Country [460] 0 0
Switzerland
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St Gallen
Country [461] 0 0
Switzerland
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Country [462] 0 0
Turkey
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Ankara
Country [463] 0 0
Turkey
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Haseki
Country [464] 0 0
Turkey
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Izmir
Country [465] 0 0
Turkey
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Diyarbakir
Country [466] 0 0
Turkey
State/province [466] 0 0
Isparta
Country [467] 0 0
Turkey
State/province [467] 0 0
Kirikkale
Country [468] 0 0
Turkey
State/province [468] 0 0
Konya
Country [469] 0 0
Ukraine
State/province [469] 0 0
Chernivtsy
Country [470] 0 0
Ukraine
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Dnipropetrovsk
Country [471] 0 0
Ukraine
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Donetsk
Country [472] 0 0
Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lugansk
Country [476] 0 0
Ukraine
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Lutsk
Country [477] 0 0
Ukraine
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Lviv
Country [478] 0 0
Ukraine
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Mykolayiv
Country [479] 0 0
Ukraine
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Odessa
Country [480] 0 0
Ukraine
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Simferopol
Country [481] 0 0
Ukraine
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Vinnitsa
Country [482] 0 0
Ukraine
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Zhaporizhzhya
Country [483] 0 0
United Kingdom
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Antrim
Country [484] 0 0
United Kingdom
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Armagh
Country [485] 0 0
United Kingdom
State/province [485] 0 0
Ayrshire
Country [486] 0 0
United Kingdom
State/province [486] 0 0
Cambridgeshire
Country [487] 0 0
United Kingdom
State/province [487] 0 0
Derbyshire
Country [488] 0 0
United Kingdom
State/province [488] 0 0
Dumfriesshire
Country [489] 0 0
United Kingdom
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East Yorkshire
Country [490] 0 0
United Kingdom
State/province [490] 0 0
Essex
Country [491] 0 0
United Kingdom
State/province [491] 0 0
Kent
Country [492] 0 0
United Kingdom
State/province [492] 0 0
Lancashire
Country [493] 0 0
United Kingdom
State/province [493] 0 0
Lincolnshire
Country [494] 0 0
United Kingdom
State/province [494] 0 0
Middlesex
Country [495] 0 0
United Kingdom
State/province [495] 0 0
Nottinghamshire
Country [496] 0 0
United Kingdom
State/province [496] 0 0
South Yorkshire
Country [497] 0 0
United Kingdom
State/province [497] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
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
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome
Trial website
https://clinicaltrials.gov/study/NCT00831441
Trial related presentations / publications
Sharma A, Hagstrom E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.
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.
Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.
Guimaraes PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4):e005490. doi: 10.1161/JAHA.117.005490.
Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.
Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.
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.
Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/NCT00831441