BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

Phase 2

Completed

• Conditions: Venous Thrombosis; Pulmonary Embolism
• Interventions: Drug: Apixaban; Drug: Enoxaparin; Drug: Warfarin; Drug: Enoxaparin Placebo; Drug: Apixaban Placebo

• Registration Number: NCT00097357
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-11-22
• Study First Submitted QC: 2004-11-22
• Study First Posted: 2004-11-23
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2008-11
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1238

Inclusion Criteria

• Undergoing elective unilateral total knee replacement surgery.
• Willing and able to undergo bilateral ascending contrast venography.
• Able to inject (by self or caregiver) study medication subcutaneously.

Exclusion Criteria

• Women of childbearing potential.
• Women who are pregnant or breastfeeding.
• Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) >=35 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A3	Enoxaparin Placebo	Apixaban: 10 mg, BID PLUS Enoxaparin Placebo
A4	Apixaban	Apixaban: 5 mg, QD PLUS Enoxaparin Placebo
A3	Apixaban	Apixaban: 10 mg, BID PLUS Enoxaparin Placebo
A2	Apixaban	Apixaban: 5 mg, BID PLUS Enoxaparin Placebo
A2	Enoxaparin Placebo	Apixaban: 5 mg, BID PLUS Enoxaparin Placebo
A1	Apixaban	Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo
A5	Apixaban	Apixaban: 10 mg, QD PLUS Enoxaparin Placebo
A5	Enoxaparin Placebo	Apixaban: 10 mg, QD PLUS Enoxaparin Placebo
A6	Apixaban	Apixaban: 20 mg, QD PLUS Enoxaparin Placebo
A6	Enoxaparin Placebo	Apixaban: 20 mg, QD PLUS Enoxaparin Placebo
A1	Enoxaparin Placebo	Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo
A4	Enoxaparin Placebo	Apixaban: 5 mg, QD PLUS Enoxaparin Placebo
E1	Apixaban Placebo	Enoxaparin: 30 mg PLUS Apixaban Placebo
E1	Enoxaparin	Enoxaparin: 30 mg PLUS Apixaban Placebo
W1	Warfarin	Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0

Primary Outcome Measures

Name	Time	Method
Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery	throughout the study

Secondary Outcome Measures

Name	Time	Method
Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery	throughout the study
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery	throughout the study
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery	throughout the study
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule	throughout the study

Trial Locations

Locations (1)

Local Institution; 🇵🇷 Ponce, Puerto Rico