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

Phase 4

Completed

• Conditions: Anticoagulation
• Interventions: Drug: Apixaban

• Registration Number: NCT01884337
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Study Start: 2015-03-24
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-04
• Results First Submitted: 2019-06-03
• Results First Submitted QC: 2019-07-31
• Results First Posted: 2019-09-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apixaban (2.5 mg)	Apixaban	Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Primary Outcome Measures

Name	Time	Method
Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days	2 weeks + 2 days for TKR, 5 weeks + 2 days for THR	TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) 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 bleeding that; 1) Is clinically acute and overt 2) 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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days	2 weeks + 2 days for TKR, 5 weeks + 2 days for THR	VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.

Trial Locations

Locations (1)

Local Institution; 🇮🇳 Pune, India