Safety Study of Apixaban in Recent Acute Coronary Syndrome
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Acute Coronary Syndrome (ACS) |
| Intervention | Drug: Apixaban Drug: Apixaban Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00313300 |
| First Received | April 10, 2006 |
| Last Updated | September 10, 2010 |
| Last verified | September 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 10, 2006 |
|---|---|
| Last Updated Date | September 10, 2010 |
| Start Date | May 2006 |
| Estimated Primary Completion Date | May 2008 |
| Current Primary Outcome Measures | Major and clinically relevant non-major bleeding [Time Frame: through end of treatment] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Safety Study of Apixaban in Recent Acute Coronary Syndrome |
|---|---|
| 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. |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition | Acute Coronary Syndrome (ACS) |
| Intervention | Drug: Apixaban Tablets, Oral, 2.5 mg, twice daily, 26 weeks Drug: Apixaban Tablets, Oral, 10 mg, once daily, 26 weeks Drug: Placebo Tablets, Oral, 0, twice daily, 26 weeks |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1715 |
| Estimated Completion Date | May 2008 |
| Estimated Primary Completion Date | May 2008 |
| Eligibility Criteria | Inclusion Criteria: - Recent (< = 7 days) Acute Coronary Syndrome (ACS). - Clinically stable on optimal treatment Exclusion Criteria: - High bleeding risk. - Ongoing anticoagulant use. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Poland, Russian Federation, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00313300 |
|---|---|
| Other Study ID Numbers | CV185-023 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Not Provided |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | September 2008 |
Locations[ + expand ][ + ]
| Scottsdale Cardiovasular Research Institute | Scottsdale, Arizona, United States, 85251 |
|---|---|
| Los Angeles County & University Of Southern Ca. Medical Cen. | Los Angeles, California, United States, 90033 |
| Radiant Research,Santa Rosa | Santa Rosa, California, United States, 95405 |
| South Denver Cardiology Associates | Littleton, Colorado, United States, 80120 |
| Watson Clinic Center For Research | Lakeland, Florida, United States, 33805 |
| Heart & Vasc Inst Of Fl | Safety Harbor, Florida, United States, 34695 |
| Indian River Medical Center | Vero Beach, Florida, United States, 32960 |
| Cardiac Disease Specialists, P.C. | Atlanta, Georgia, United States, 30309 |
| Georgia Heart Specialists | Covington, Georgia, United States, 30014 |
| Heartcare Midwest | Peoria, Illinois, United States, 61614 |
| The Care Group, Llc. | Indianapolis, Indiana, United States, 46290 |
| Iowa Heart Center | Des Moines, Iowa, United States, 50314 |
| University Of Kentucky | Lexington, Kentucky, United States, 40536 |
| William Beaumont Hospital-Troy | Troy, Michigan, United States, 48085 |
| New York Cardiovascular Associates | New York, New York, United States, 10001 |
| Unc Hospitals, Department Of Medicine | Chapel Hill, North Carolina, United States, 27599 |
| Dumc | Durham, North Carolina, United States, 27705 |
| Carolina Heart Specialists | Gastonia, North Carolina, United States, 28054 |
| Piedmont Cardiology Associates | Hickory, North Carolina, United States, 28602 |
| Wake Forest Univ Health Sciences | Winston-Salem, North Carolina, United States, 27157 |
| Midwest Cardiology Research Foundation | Columbus, Ohio, United States, 43214 |
| The Dayton Heart Center | Dayton, Ohio, United States, 45414 |
| Oklahoma Cardiovascular Research Group | Oklahoma City, Oklahoma, United States, 73120 |
| Geisinger Clinic - Cardiology | Danville, Pennsylvania, United States, 17822 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States, 17033 |
| Rhode Island Hospital | Providence, Rhode Island, United States, 02903 |
| Cardiovascular Associates, P.C | Kingsport, Tennessee, United States, 37660 |
| University Of Texas Medical School - San Antonio | San Antonio, Texas, United States, 78229 |
| Tyler Cardiovascular Consultants | Tyler, Texas, United States, 75701 |
| Virginia Commonwealth University | Richmond, Virginia, United States, 23298 |
| Local Institution | Feldkirch, Austria, 6800 |
| Local Institution | Wien, Austria, 1160 |
| Local Institution | Wien, Austria, 1090 |
| Local Institution | Huy, Luik, Belgium, 4500 |
| Local Institution | Aalst, Belgium, 9300 |
| Local Institution | Antwerpen, Belgium, 2020 |
| Local Institution | Brasschaat, Belgium, 2930 |
| Local Institution | Brugge, Belgium, 8000 |
| Local Institution | Brussels, Belgium, 1090 |
| Local Institution | Genk, Belgium, 3600 |
| Local Institution | Edmonton, Alberta, Canada, T5H 3V9 |
| Local Institution | Edmonton, Alberta, Canada, T6K 4C1 |
| Local Institution | Edmonton, Alberta, Canada, T6G 2B7 |
| Local Institution | Victoria, British Columbia, Canada, V8R 4R2 |
| Local Institution | St. John'S, Newfoundland and Labrador, Canada, A1B 3V6 |
| Local Institution | Belleville, Ontario, Canada, K8N1E6 |
| Local Institution | Chatham, Ontario, Canada, N7L 1B9 |
| Local Institution | Hamilton, Ontario, Canada, L8L 2X2 |
| Local Institution | London, Ontario, Canada, N6A 5A5 |
| Local Institution | Oshawa, Ontario, Canada, L1H 1B9 |
| Local Institution | Montreal, Quebec, Canada, H1T 2M4 |
| Local Institution | Montreal, Quebec, Canada, H2X 3J4 |
| Local Institution | Montreal, Quebec, Canada, H1T 1C8 |
| Local Institution | St. Charles-Borromee, Quebec, Canada, J6E 6J2 |
| Local Institution | Terrebonne, Quebec, Canada, J6V 2H2 |
| Local Institution | Arhus C, Denmark, 8000 |
| Local Institution | Copenhagen, Denmark, 2100 |
| Local Institution | Esbjerg, Denmark, 6700 |
| Local Institution | Frederiksberg, Denmark, 2000 |
| Local Institution | Glostrup, Denmark, 2600 |
| Local Institution | Hellerup, Denmark, 2900 |
| Local Institution | Herning, Denmark, 7400 |
| Local Institution | Randers, Denmark, DK-8900 |
| Local Institution | Amiens Cedex 1, France, 80054 |
| Local Institution | Cholet, France, 49300 |
| Local Institution | Dijon, France, 21079 |
| Local Institution | Nantes Cedex 01, France, 44093 |
| Local Institution | Paris Cedex 13, France, 75651 |
| Local Institution | Pessac Cedex, France, 33604 |
| Local Institution | Roubaix Cedex 1, France, 59056 |
| Local Institution | Toulouse, France, 31403 |
| Local Institution | Berlin, Germany, 12351 |
| Local Institution | Berlin, Germany, 12559 |
| Local Institution | Duren, Germany, 52351 |
| Local Institution | Halle / Saale, Germany, 06120 |
| Local Institution | Hannover, Germany, 30625 |
| Local Institution | Krefeld, Germany, 47805 |
| Local Institution | Langen, Germany, 63225 |
| Local Institution | Ludwigshafen, Germany, 67063 |
| Local Institution | Witten, Germany, 58455 |
| Local Institution | Afula, Israel, 18101 |
| Local Institution | Hadera, Israel, 38100 |
| Local Institution | Haifa, Israel, 34362 |
| Local Institution | Haifa, Israel, 31096 |
| Local Institution | Jerusalem, Israel, 91120 |
| Local Institution | Jerusalem, Israel, 91031 |
| Local Institution | Jerusalem, Israel, 91240 |
| Local Institution | Kfar-Saba, Israel, 44281 |
| Local Institution | Nazareth, Israel, 16100 |
| Local Institution | Petach Tikva, Israel, 49100 |
| Local Institution | Rehovot, Israel, 76100 |
| Local Institution | Safed, Israel, 13100 |
| Local Institution | Tel Aviv, Israel, 64239 |
| Local Institution | Roma, Italy, 00168 |
| Local Institution | Bialystok, Poland, 15-276 |
| Local Institution | Bydgoszcz, Poland, 85-826 |
| Local Institution | Bydgoszcz, Poland, 85-094 |
| Local Institution | Bydgoszcz, Poland, 85-168 |
| Local Institution | Cracow, Poland, 31-202 |
| Local Institution | Gdansk, Poland, 80-952 |
| Local Institution | Katowice, Poland, 40-635 |
| Local Institution | Krakow, Poland, 31-501 |
| Local Institution | Lodz, Poland, 91-347 |
| Local Institution | Opole, Poland, 45-418 |
| Local Institution | Torun, Poland, 87-100 |
| Local Institution | Warszawa, Poland, 04-628 |
| Local Institution | Zielona Gora, Poland, 65-046 |
| Local Institution | Kemerovo, Russian Federation, 650002 |
| Local Institution | Moscow, Russian Federation, 121552 |
| Local Institution | Moscow, Russian Federation, 111020 |
| Local Institution | Moscow, Russian Federation, 129327 |
| Local Institution | Moscow, Russian Federation, 115487 |
| Local Institution | Moscow, Russian Federation, 127473 |
| Local Institution | Moscow, Russian Federation, 105229 |
| Local Institution | Moscow, Russian Federation, 119620 |
| Local Institution | Saint Petersburg, Russian Federation, 195067 |
| Local Institution | Saint Petersburg, Russian Federation, 191104 |
| Local Institution | Saint Petersburg, Russian Federation, 197110 |
| Local Institution | Saint Petersburg, Russian Federation, 193312 |
| Local Institution | Saratov, Russian Federation, 410028 |
| Local Institution | St. Petersburg, Russian Federation, 194156 |
| Local Institution | St.Petersburg, Russian Federation, 192242 |
| Local Institution | Yaroslav, Russian Federation, 150062 |
| Local Institution | Yaroslavl, Russian Federation, 150003 |
| Local Institution | Baracaldo (Vizcaya), Spain, 48903 |
| Local Institution | Barcelona, Spain, 08035 |
| Local Institution | Hospitalet Llobregat Barcelona, Spain, 08907 |
| Local Institution | Leon, Spain, 24071 |
| Local Institution | Madrid, Spain, 28046 |
| Local Institution | Malaga, Spain, 29010 |
| Local Institution | Oviedo, Spain, 33006 |
| Local Institution | Santiago De Compostela, Spain, 15706 |
| Local Institution | Sevilla, Spain, 41071 |
| Local Institution | Tarragona, Spain, 43007 |
| Local Institution | Valladolid, Spain, 47010 |
| Local Institution | Villajoyosa, Spain, 03570 |
| Local Institution | Goteborg, Sweden, SE-416 85 |
| Local Institution | Goteborg, Sweden, 413 45 |
| Local Institution | Malmo, Sweden, 205 02 |
| Local Institution | Orebro, Sweden, 701 85 |
| Local Institution | Stockholm, Sweden, 141 86 |
| Local Institution | Sundsvall, Sweden, 851 86 |
| Local Institution | Uppsala, Sweden, 751 85 |
| Local Institution | Stockport, Cheshire, United Kingdom, SK2 7JE |
| Local Institution | Harrow, Middlesex, United Kingdom, HA1 3UJ |
| Local Institution | Edinburgh, Midlothian, United Kingdom, EH16 4SB |
| Local Institution | Portadown, N. Ireland, United Kingdom, BT63 5QQ |
| Local Institution | Sheffield, South Yorkshire, United Kingdom, S10 2JF |
| Local Institution | York, Yorkshire, United Kingdom, YO31 8HE |
| Local Institution | Croydon, United Kingdom, CR7 7YE |
| Local Institution | Leicester, United Kingdom, LE3 9QP |