Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Overview[ - collapse ][ - ]
Purpose | The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement |
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Condition | Anticoagulation |
Intervention | Drug: Apixaban |
Phase | Phase 4 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT01884337 |
First Received | June 6, 2013 |
Last Updated | October 7, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 6, 2013 |
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Last Updated Date | October 7, 2013 |
Start Date | December 2013 |
Estimated Primary Completion Date | February 2015 |
Current Primary Outcome Measures | The primary study endpoint is a composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding/clinically relevant non-major bleeding (CRNM) in subjects undergoing elective total knee or hip replacement [Time Frame: Up to End of Treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects)] [Designated as safety issue: Yes]ISTH major bleeding is; Fatal or Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours CRNM bleeding is; Is clinically acute and overt Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis THR = Total hip replacement TKR = Total knee replacement |
Current Secondary Outcome Measures | Composite of VTE/all cause death, where VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism [Time Frame: Up to end of treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects)] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery |
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Official Title | A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery |
Brief Summary | The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Anticoagulation |
Intervention | Drug: Apixaban Other Names:
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Study Arm (s) | Experimental: Apixaban (2.5 mg) Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 500 |
Estimated Completion Date | February 2015 |
Estimated Primary Completion Date | February 2015 |
Eligibility Criteria | Inclusion Criteria: - Age ≥18 years - Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement Exclusion Criteria: - Women who are pregnant or breastfeeding - Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative - Active bleeding or at high risk for bleeding. - Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery - Active hepatobiliary disease - Hemoglobin <9 g/dL - Platelet count <100,000/mm3 - Creatinine clearance <30 mL/min |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: For Site information please email: Clinical.Trials@bms.com |
Location Countries | India |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01884337 |
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Other Study ID Numbers | CV185-158 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Pfizer |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
Local Institution | Ahmedabad, India, 380015 Contact: Site 0011Not yet recruiting |
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Local Institution | Ahmedabad, India, 380054 Contact: Site 0049Not yet recruiting |
Local Institution | Ahmedabad, India, 380060 Contact: Site 0047Not yet recruiting |
Local Institution | Bangalore, India, 560054 Contact: Site 0013Not yet recruiting |
Local Institution | Bangalore, India, 560 034 Contact: Site 0057Not yet recruiting |
Local Institution | Bangalore, India, 560076 Contact: Site 0054Not yet recruiting |
Local Institution | Bangalore, India, 560076 Contact: Site 0024Not yet recruiting |
Local Institution | Belgaum, India, 590010 Contact: Site 0058Not yet recruiting |
Local Institution | Chandigarh, India, 160030 Contact: Site 0023Not yet recruiting |
Local Institution | Chandigarh, India, 160012 Contact: Site 0040Not yet recruiting |
Local Institution | Chennai, India, 600116 Contact: Site 0021Not yet recruiting |
Local Institution | Chennai, India, 6000006 Contact: Site 0053Not yet recruiting |
Local Institution | Hyderabad, India, 500082 Contact: Site 0043Not yet recruiting |
Local Institution | Hyderabad, India, 500096 Contact: Site 0010Not yet recruiting |
Local Institution | Hyderabad, India, 500001 Contact: Site 0055Not yet recruiting |
Local Institution | Kolkata, India, 700107 Contact: Site 0035Not yet recruiting |
Local Institution | Lucknow, India, 226003 Contact: Site 0026Not yet recruiting |
Local Institution | Ludhiana, India, 141001 Contact: Site 0030Not yet recruiting |
Local Institution | Mangalore, India, 575001 Contact: Site 0017Not yet recruiting |
Local Institution | Mohali, India, 160062 Contact: Site 0034Not yet recruiting |
Local Institution | Mumbai, India, 400026 Contact: Site 0001Not yet recruiting |
Local Institution | New Delhi, India, 110029 Contact: Site 0052Not yet recruiting |
Local Institution | Pune, India, 411044 Contact: Site 0016Not yet recruiting |
Local Institution | Pune, India, 411004 Contact: Site 0019Not yet recruiting |