Acute Coronary Syndrome (ACS)Phase 2NCT00313300
Safety Study of Apixaban in Recent Acute Coronary Syndrome
A Phase 2 study testing Apixaban in people with Acute Coronary Syndrome (ACS), run by Bristol-Myers Squibb at 151 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,741 participants
- Where
- 151 sitesin 14 countries
- Study dates
- May 2006to May 2008
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent (< = 7 days) Acute Coronary Syndrome (ACS).
- Clinically stable on optimal treatment
Who cannot join
- 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
Trial locations and contacts
151 sites in 14 countries.
151 sites in 14 countries
United States30 sites
Cardiac Disease Specialists, P.C.
Atlanta, Georgia, 30309
Unc Hospitals, Department Of Medicine
Chapel Hill, North Carolina, 27599
Midwest Cardiology Research Foundation
Columbus, Ohio, 43214
Georgia Heart Specialists
Covington, Georgia, 30014
Geisinger Clinic - Cardiology
Danville, Pennsylvania, 17822
The Dayton Heart Center
Dayton, Ohio, 45414
Iowa Heart Center
Des Moines, Iowa, 50314
Dumc
Durham, North Carolina, 27705
Carolina Heart Specialists
Gastonia, North Carolina, 28054
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Piedmont Cardiology Associates
Hickory, North Carolina, 28602
The Care Group, Llc.
Indianapolis, Indiana, 46290
Cardiovascular Associates, P.C
Kingsport, Tennessee, 37660
Watson Clinic Center For Research
Lakeland, Florida, 33805
University Of Kentucky
Lexington, Kentucky, 40536
South Denver Cardiology Associates
Littleton, Colorado, 80120
Los Angeles County & University Of Southern Ca. Medical Cen.
Los Angeles, California, 90033
New York Cardiovascular Associates
New York, New York, 10001
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Heartcare Midwest
Peoria, Illinois, 61614
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
Heart & Vasc Inst Of Fl
Safety Harbor, Florida, 34695
University Of Texas Medical School - San Antonio
San Antonio, Texas, 78229
Radiant Research,Santa Rosa
Santa Rosa, California, 95405
Scottsdale Cardiovasular Research Institute
Scottsdale, Arizona, 85251
William Beaumont Hospital-Troy
Troy, Michigan, 48085
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
Indian River Medical Center
Vero Beach, Florida, 32960
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, 27157
Russia17 sites
Local Institution
Kemerovo, 650002
Local Institution
Moscow, 105229
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Moscow, 111020
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Moscow, 115487
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Moscow, 119620
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Moscow, 121552
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Moscow, 127473
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Moscow, 129327
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Saint Petersburg, 191104
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Saint Petersburg, 192242
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Saint Petersburg, 193312
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Saint Petersburg, 194156
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Saint Petersburg, 195067
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Saint Petersburg, 197110
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Saratov, 410028
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Yaroslav, 150062
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Yaroslavl, 150003
Canada15 sites
Local Institution
Belleville, Ontario, K8N1E6
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Chatham, Ontario, N7L 1B9
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Edmonton, Alberta, T5H 3V9
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Edmonton, Alberta, T6G 2B7
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Edmonton, Alberta, T6K 4C1
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Hamilton, Ontario, L8L 2X2
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London, Ontario, N6A 5A5
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Montreal, Quebec, H1T 1C8
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2X 3J4
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Oshawa, Ontario, L1H 1B9
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Saint-Charles-Borromée, Quebec, J6E 6J2
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St. John's, Newfoundland and Labrador, A1B 3V6
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Terrebonne, Quebec, J6V 2H2
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Victoria, British Columbia, V8R 4R2
Israel13 sites
Local Institution
Afula, 18101
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Hadera, 38100
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Haifa, 31096
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Haifa, 34362
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Jerusalem, 91031
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Jerusalem, 91120
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Jerusalem, 91240
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Kfar Saba, 44281
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Nazareth, 16100
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Petah Tikva, 49100
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Rehovot, 76100
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Safed, 13100
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Tel Aviv, 64239
Poland13 sites
Local Institution
Bialystok, 15-276
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Bydgoszcz, 85-094
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Bydgoszcz, 85-168
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Bydgoszcz, 85-826
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Cracow, 31-202
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Gdansk, 80-952
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Katowice, 40-635
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Krakow, 31-501
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Lodz, 91-347
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Opole, 45-418
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Torun, 87-100
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Warsaw, 04-628
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Zielona Góra, 65-046
Spain12 sites
Local Institution
Baracaldo (Vizcaya), 48903
Local Institution
Barcelona, 08035
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Hospitalet Llobregat Barcelona, 08907
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León, 24071
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Madrid, 28046
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Málaga, 29010
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Oviedo, 33006
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Santiago de Compostela, 15706
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Seville, 41071
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Tarragona, 43007
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Valladolid, 47010
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Villajoyosa, 03570
Germany9 sites
Local Institution
Berlin, 12351
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Berlin, 12559
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Düren, 52351
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Halle, 06120
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Hanover, 30625
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Krefeld, 47805
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Langen, 63225
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Ludwigshafen, 67063
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Witten, 58455
Denmark8 sites
Local Institution
Arhus C, 8000
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Copenhagen, 2100
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Esbjerg, 6700
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Frederiksberg, 2000
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Glostrup Municipality, 2600
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Hellerup, 2900
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Herning, 7400
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Randers, DK-8900
France8 sites
Local Institution
Amiens, 80054
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Cholet, 49300
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Dijon, 21079
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Nantes, 44093
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Paris, 75651
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Pessac, 33604
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Roubaix, 59056
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Toulouse, 31403
United Kingdom8 sites
Local Institution
Croydon, CR7 7YE
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Edinburgh, Midlothian, EH16 4SB
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Harrow, Middlesex, HA1 3UJ
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Leicester, LE3 9QP
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Portadown, Northern Ireland, BT63 5QQ
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Sheffield, South Yorkshire, S10 2JF
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Stockport, Cheshire, SK2 7JE
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York, Yorkshire, YO31 8HE
Belgium7 sites
Local Institution
Aalst, 9300
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Antwerp, 2020
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Brasschaat, 2930
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Bruges, 8000
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Brussels, 1090
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Genk, 3600
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Huy, Luik, 4500
Sweden7 sites
Local Institution
Gothenburg, 413 45
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Gothenburg, SE-416 85
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Malmö, 205 02
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Örebro, 701 85
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Stockholm, 141 86
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Sundsvall, 851 86
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Uppsala, 751 85
Austria3 sites
Local Institution
Feldkirch, 6800
Local Institution
Vienna, 1090
Local Institution
Vienna, 1160
About this study
Official title: 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.
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.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- Apixaban, Placebo
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Tablets, Oral, 2.5 mg, twice daily, 26 weeks
ApixabanDrug
Tablets, Oral, 10 mg, once daily, 26 weeks
PlaceboDrug
Tablets, Oral, 0, twice daily, 26 weeks
ApixabanDrug
Tablets, Oral 10 mg, twice daily, 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Apixaban |
| A2 | Experimental | Not described Receives: Drug: Apixaban |
| A3 | Placebo comparator | Not described Receives: Drug: Placebo |
| A4 | Experimental | Not described Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.
Measured: 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
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 (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.
Measured: 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
Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B
Measured: 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
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).
Measured: 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
Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Measured: Day of randomization and ends on high dose termination date, 1-Oct-2007
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Measured: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Measured: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Measured: Day of randomization up to high dose termination, 1-Oct-2007
Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).
Measured: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313300
- Sponsor's protocol ID
- CV185-023
- Status last verified
- Nov 2015
- First submitted
- 10 Apr 2006
- Last updated
- 30 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19470889