BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097357

Enrollment

1238

Registered

2004-11-23

Start date

2004-10-31

Completion date

2005-12-31

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thrombosis, Pulmonary Embolism

Keywords

Prevention of deep vein thrombosis and pulmonary embolism, Preventive therapy

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.

Interventions

DRUGApixaban

Tablets, Oral, 12 +/- 2 days

DRUGEnoxaparin

Injection, SQ, Q12H, 12 +/- 2 days

DRUGWarfarin

Tablets, Oral, QD, 12 +/- 2 days

DRUGEnoxaparin Placebo

Injection, SQ, BID, 12 +/- 2 days

DRUGApixaban Placebo

Tablets, Oral, BID, 12 +/- 2 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Argentina, Australia, Canada, Denmark, Israel, Mexico, Poland, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026