Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied. |
|---|---|
| Condition | Deep Vein Thrombosis Pulmonary Embolism |
| Intervention | Drug: Enoxaparin + Placebo Drug: Apixaban + Placebo |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00371683 |
| First Received | August 30, 2006 |
| Last Updated | September 10, 2010 |
| Last verified | August 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 30, 2006 |
|---|---|
| Last Updated Date | September 10, 2010 |
| Start Date | November 2006 |
| Estimated Primary Completion Date | May 2008 |
| Current Primary Outcome Measures | A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [Time Frame: after 12 days of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery |
|---|---|
| Official Title | A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery |
| Brief Summary | The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition |
|
| Intervention | Drug: Enoxaparin + Placebo Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period Other Names: Lovenox®Drug: Apixaban + Placebo Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 3202 |
| Estimated Completion Date | May 2008 |
| Estimated Primary Completion Date | May 2008 |
| Eligibility Criteria | Inclusion Criteria: - Men and non-pregnant, non-breastfeeding women - 18 years or older - Scheduled for knee replacement surgery Exclusion Criteria: - hereditary or acquired bleeding disorders - clotting disorders - bleeding or high risk for bleeding - drugs that affect bleeding or coagulation |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Australia, Brazil, Canada, Denmark, Hungary, Israel, Mexico, Poland, Russian Federation, Sweden, Turkey |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00371683 |
|---|---|
| Other Study ID Numbers | CV185-034 |
| 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 | August 2009 |
Locations[ + expand ][ + ]
| Capstone Clinical Trials, Inc | Birmingham, Alabama, United States, 35205 |
|---|---|
| Capstone Clinical Trials, Inc | Birmingham, Alabama, United States, 35209 |
| West Alabama Research, Inc. | Tuscaloosa, Alabama, United States, 35406 |
| Martin Bowen Hefley Orthopedics | Little Rock, Arkansas, United States, 72205 |
| Colorado Orthopedic Consultants, Pc | Aurora, Colorado, United States, 80012 |
| Colorado Joint Replacement | Denver, Colorado, United States, 80210 |
| Jdpmedical Research | Denver, Colorado, United States, 80230 |
| Orhtopaedic Physicians Of Colorado, P.C. | Englewood, Colorado, United States, 80113 |
| Orthopedics Assocs Of Hartford | Hartford, Connecticut, United States, 06106 |
| Anthony S. Unger, Md | Washington, District of Columbia, United States, 20006 |
| Bay Pines Va Medical Center | Bay Pines, Florida, United States, 33744 |
| Pab Clinical Research | Brandon, Florida, United States, 33511 |
| Jacksonville Center For Clinical Research | Jacksonville, Florida, United States, 32216 |
| Mark W. Hollmann, Md | Orange City, Florida, United States, 32763 |
| Jewett Orthopaedic Clinic | Winter Park, Florida, United States, 32789 |
| Atlanta Knee And Sports Medicine | Decatur, Georgia, United States, 30033 |
| Intermountain Orthopaedics | Boise, Idaho, United States, 83702 |
| Americana Orthopedics | Boise, Idaho, United States, 83702 |
| Bluegrass Orthopaedics/Bmr | Lexington, Kentucky, United States, 40509 |
| Charleston Orthopaedic Assocs. | Charleston, South Carolina, United States, 29414 |
| Bone & Joint Clinic Of Houston | Houston, Texas, United States, 77030 |
| Kelsey Seybold Clinic | Houston, Texas, United States, 77025 |
| Gill Orthopedic Center | Lubbock, Texas, United States, 79410 |
| Robert R. King, Md | Lubbock, Texas, United States, 79410 |
| Unlimited Research | San Antonio, Texas, United States, 78217 |
| Local Institution | Capital Federal, Buenos Aires, Argentina, 1012 |
| Local Institution | Capital Federal, Buenos Aires, Argentina, 1426 |
| Local Institution | Buenos Aires, Argentina, 7540 |
| Local Institution | Buenos Aires, Argentina, 1280 |
| Local Institution | Buenos Aires, Argentina, C1181 |
| Local Institution | Buenos Aires, Argentina, 1425 |
| Local Institution | Cordoba, Argentina, 5000 |
| Local Institution | Garran, Australian Capital Territory, Australia, 2605 |
| Local Institution | Camperdown, New South Wales, Australia, NSW 2050 |
| Local Institution | Caringbah, New South Wales, Australia, 2229 |
| Local Institution | Lismore, New South Wales, Australia, 2480 |
| Local Institution | Gold Coast, Queensland, Australia, 4215 |
| Local Institution | Adelaide, South Australia, Australia, 5011 |
| Local Institution | Bedford Park, South Australia, Australia, 5042 |
| Local Institution | Box Hill, Victoria, Australia, 3128 |
| Local Institution | Windsor, Victoria, Australia, 3181 |
| Local Institution | Perth, Western Australia, Australia, 6001 |
| Local Institution | Curitiba, Parana, Brazil, 80060 |
| Local Institution | Porto Alegre, Rio Grande Do Sul, Brazil, 90035 |
| Local Institution | Porto Alegre, Rs, Rio Grande Do Sul, Brazil, 90020 |
| Local Institution | Campinas, Sao Paulo, Brazil, 13083 |
| Local Institution | S�o Paulo, Sao Paulo, Brazil, 05403 |
| Local Institution | Edmonton, Alberta, Canada, T6G 2R7 |
| Local Institution | Ajax, Ontario, Canada, L1S 2J5 |
| Local Institution | Burlington, Ontario, Canada, L7R 4B7 |
| Local Institution | Cambridge, Ontario, Canada, N1R 7L7 |
| Local Institution | Chatham, Ontario, Canada, N7L 4T1 |
| Local Institution | Dartmouth, Ontario, Canada, B2Y 2N6 |
| Local Institution | Guelph, Ontario, Canada, N1E 6L9 |
| Local Institution | Lindsay, Ontario, Canada, K9V 4M8 |
| Local Institution | Newmarket, Ontario, Canada, L3Y 5G8 |
| Local Institution | Niagara Falls, Ontario, Canada, L2E 6X2 |
| Local Institution | Sarnia, Ontario, Canada, N7T 6H3 |
| Local Institution | Scarborough, Ontario, Canada, M1S 4T7 |
| Local Institution | Scarborough, Ontario, Canada, M3C 1W3 |
| Local Institution | St. Catharines, Ontario, Canada, L2R 7P3 |
| Local Institution | Stratford, Ontario, Canada, N5A 2N4 |
| Local Institution | Waterloo, Ontario, Canada, N2J 1C4 |
| Local Institution | Windsor, Ontario, Canada, N8W 1E6 |
| Local Institution | Charlottetown, Prince Edward Island, Canada, C1A 1L2 |
| Local Institution | Montreal, Quebec, Canada, H4J 1C5 |
| Local Institution | Quebec, Canada, G1L 3L5 |
| Local Institution | Horsholm, Denmark, 2970 |
| Local Institution | Kopenhamn S, Denmark, 2300 |
| Local Institution | Kecskemet, Hungary, 6000 |
| Local Institution | Szekesfehervar, Hungary, 8000 |
| Local Institution | Szolnok, Hungary, 5008 |
| Local Institution | Afula, Israel, 18101 |
| Local Institution | Beer-Sheva, Israel, 84101 |
| Local Institution | Haifa, Israel, 31096 |
| Local Institution | Holon, Israel, 58100 |
| Local Institution | Kfar-Saba, Israel, 44281 |
| Local Institution | Petach-Tikva, Israel, 49100 |
| Local Institution | Rehovot, Israel, 76100 |
| Local Institution | Zerifin, Israel, 70300 |
| Local Institution | Tijuana, Baja California, Mexico, 22010 |
| Local Institution | Df, Distrito Federal, Mexico, 07760 |
| Local Institution | Df, Distrito Federal, Mexico, 05300 |
| Local Institution | Df, Distrito Federal, Mexico, 01030 |
| Local Institution | Guadalajara, Jalisco, Mexico, 44280 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64000 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64460 |
| Local Institution | Cd Madero, Tamaulipas, Mexico, 89240 |
| Local Institution | Jalapa, Veracruz, Mexico, 91020 |
| Local Institution | Merida, Yucatan, Mexico, 97133 |
| Local Institution | Merida, Yucatan, Mexico, 97070 |
| Local Institution | Chihuahua, Mexico, 31000 |
| Local Institution | Bialystok, Poland, 15276 |
| Local Institution | Krakow, Poland, 31-826 |
| Local Institution | Lodz, Poland, 91002 |
| Local Institution | Lublin, Poland, 20954 |
| Local Institution | Szczecin, Poland, 71252 |
| Local Institution | Warszawa, Poland, 02005 |
| Local Institution | Warszawa, Poland, 00909 |
| Local Institution | Moscow, Russian Federation, 117333 |
| Local Institution | Samara, Russian Federation, 443095 |
| Local Institution | St. Petersburg, Russian Federation, 195257 |
| Local Institution | Goteborg, Sweden, 416 85 |
| Local Institution | Adana, Turkey, 01330 |
| Local Institution | Bursa, Turkey, 16059 |
| Local Institution | Mersin, Turkey, 33163 |
| Local Institution | Trabzon, Turkey, 61030 |