Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

• Status: Completed
• Trial end date: 2018-06-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Pfizer
• Treatments: Apixaban

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