Status:
COMPLETED
Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Pfizer
Conditions:
Anticoagulation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2018
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT01884337
Start Date
March 24 2015
End Date
June 4 2018
Last Update
November 29 2019
Active Locations (20)
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1
Local Institution
Kozhikode, Kerala, India, 673008
2
Local Institution
Ahmedabad, India, 380015
3
Local Institution
Ahmedabad, India, 380016
4
Local Institution
Ahmedabad, India, 380060