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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Anticoagulation

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01884337

CV185-158

Details and patient eligibility

About

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

Enrollment: 557 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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557 participants in 1 patient group

Apixaban (2.5 mg)

Experimental group

Description:

Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Treatment:

Drug: Apixaban