Safety Study of Apixaban in Recent Acute Coronary Syndrome
A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.
1 other identifier
interventional
1,741
14 countries
151
Brief Summary
The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
October 15, 2015
CompletedDecember 30, 2015
November 1, 2015
2 years
April 10, 2006
September 11, 2015
November 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.
From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Secondary Outcomes (9)
Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Randomization to 182 days after randomization (183 days)
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study
Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Day of randomization to 182 days after day of randomization (183 days)
Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Day of randomization and ends on high dose termination date, 1-Oct-2007
- +4 more secondary outcomes
Study Arms (4)
A1
ACTIVE COMPARATORA2
EXPERIMENTALA3
PLACEBO COMPARATORA4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Recent (\< = 7 days) Acute Coronary Syndrome (ACS).
- Clinically stable on optimal treatment
You may not qualify if:
- High bleeding risk.
- Ongoing anticoagulant use.
- Need for chronic (\>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (\>325 mg/day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (151)
Scottsdale Cardiovasular Research Institute
Scottsdale, Arizona, 85251, United States
Los Angeles County & University Of Southern Ca. Medical Cen.
Los Angeles, California, 90033, United States
Radiant Research,Santa Rosa
Santa Rosa, California, 95405, United States
South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
Watson Clinic Center For Research
Lakeland, Florida, 33805, United States
Heart & Vasc Inst Of Fl
Safety Harbor, Florida, 34695, United States
Indian River Medical Center
Vero Beach, Florida, 32960, United States
Cardiac Disease Specialists, P.C.
Atlanta, Georgia, 30309, United States
Georgia Heart Specialists
Covington, Georgia, 30014, United States
Heartcare Midwest
Peoria, Illinois, 61614, United States
The Care Group, Llc.
Indianapolis, Indiana, 46290, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
University Of Kentucky
Lexington, Kentucky, 40536, United States
William Beaumont Hospital-Troy
Troy, Michigan, 48085, United States
New York Cardiovascular Associates
New York, New York, 10001, United States
Unc Hospitals, Department Of Medicine
Chapel Hill, North Carolina, 27599, United States
Dumc
Durham, North Carolina, 27705, United States
Carolina Heart Specialists
Gastonia, North Carolina, 28054, United States
Piedmont Cardiology Associates
Hickory, North Carolina, 28602, United States
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, 27157, United States
Midwest Cardiology Research Foundation
Columbus, Ohio, 43214, United States
The Dayton Heart Center
Dayton, Ohio, 45414, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
Geisinger Clinic - Cardiology
Danville, Pennsylvania, 17822, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Cardiovascular Associates, P.C
Kingsport, Tennessee, 37660, United States
University Of Texas Medical School - San Antonio
San Antonio, Texas, 78229, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Local Institution
Feldkirch, 6800, Austria
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Vienna, 1090, Austria
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Vienna, 1160, Austria
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Huy, Luik, 4500, Belgium
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Aalst, 9300, Belgium
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Antwerp, 2020, Belgium
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Brasschaat, 2930, Belgium
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Bruges, 8000, Belgium
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Brussels, 1090, Belgium
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Genk, 3600, Belgium
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Edmonton, Alberta, T5H 3V9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Edmonton, Alberta, T6K 4C1, Canada
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Victoria, British Columbia, V8R 4R2, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Belleville, Ontario, K8N1E6, Canada
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Chatham, Ontario, N7L 1B9, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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London, Ontario, N6A 5A5, Canada
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Oshawa, Ontario, L1H 1B9, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Terrebonne, Quebec, J6V 2H2, Canada
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Arhus C, 8000, Denmark
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Copenhagen, 2100, Denmark
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Esbjerg, 6700, Denmark
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Frederiksberg, 2000, Denmark
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Glostrup Municipality, 2600, Denmark
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Hellerup, 2900, Denmark
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Herning, 7400, Denmark
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Randers, DK-8900, Denmark
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Amiens, 80054, France
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Cholet, 49300, France
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Dijon, 21079, France
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Nantes, 44093, France
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Paris, 75651, France
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Pessac, 33604, France
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Roubaix, 59056, France
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Toulouse, 31403, France
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Berlin, 12351, Germany
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Berlin, 12559, Germany
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Düren, 52351, Germany
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Halle, 06120, Germany
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Hanover, 30625, Germany
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Krefeld, 47805, Germany
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Langen, 63225, Germany
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Ludwigshafen, 67063, Germany
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Witten, 58455, Germany
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Afula, 18101, Israel
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Hadera, 38100, Israel
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Haifa, 31096, Israel
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Haifa, 34362, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Jerusalem, 91240, Israel
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Kfar Saba, 44281, Israel
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Nazareth, 16100, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Safed, 13100, Israel
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Tel Aviv, 64239, Israel
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Roma, 00168, Italy
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-094, Poland
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Bydgoszcz, 85-168, Poland
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Bydgoszcz, 85-826, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-635, Poland
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Krakow, 31-202, Poland
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Krakow, 31-501, Poland
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Lodz, 91-347, Poland
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Opole, 45-418, Poland
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Torun, 87-100, Poland
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Warsaw, 04-628, Poland
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Zielona Góra, 65-046, Poland
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Kemerovo, 650002, Russia
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Moscow, 105229, Russia
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Moscow, 111020, Russia
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Moscow, 115487, Russia
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Moscow, 119620, Russia
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Moscow, 121552, Russia
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Moscow, 127473, Russia
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Moscow, 129327, Russia
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Saint Petersburg, 191104, Russia
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Saint Petersburg, 192242, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 194156, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197110, Russia
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Saratov, 410028, Russia
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Yaroslavl, 150003, Russia
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Yaroslav, 150062, Russia
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Baracaldo (Vizcaya), 48903, Spain
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Barcelona, 08035, Spain
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Hospitalet Llobregat Barcelona, 08907, Spain
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León, 24071, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Oviedo, 33006, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41071, Spain
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Tarragona, 43007, Spain
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Valladolid, 47010, Spain
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Villajoyosa, 03570, Spain
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Gothenburg, 413 45, Sweden
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Gothenburg, SE-416 85, Sweden
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Malmo, 205 02, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 141 86, Sweden
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Sundsvall, 851 86, Sweden
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Uppsala, 751 85, Sweden
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Stockport, Cheshire, SK2 7JE, United Kingdom
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Harrow, Middlesex, HA1 3UJ, United Kingdom
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Edinburgh, Midlothian, EH16 4SB, United Kingdom
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Portadown, Northern Ireland, BT63 5QQ, United Kingdom
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Sheffield, South Yorkshire, S10 2JF, United Kingdom
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York, Yorkshire, YO31 8HE, United Kingdom
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Croydon, CR7 7YE, United Kingdom
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Leicester, LE3 9QP, United Kingdom
Related Publications (1)
APPRAISE Steering Committee and Investigators; Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.
PMID: 19470889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
May 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
December 30, 2015
Results First Posted
October 15, 2015
Record last verified: 2015-11