BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00097357
First received: November 22, 2004
Last updated: February 27, 2010
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Venous Thrombosis
Pulmonary Embolism
Drug: Apixaban
Drug: Enoxaparin
Drug: Warfarin
Drug: Enoxaparin Placebo
Drug: Apixaban Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: throughout the study ]
  • To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule [ Time Frame: throughout the study ]

Enrollment: 1238
Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1

Apixaban: 2.5 mg, BID

PLUS

Enoxaparin Placebo

Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Name: BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A2

Apixaban: 5 mg, BID

PLUS

Enoxaparin Placebo

Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Name: BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A3

Apixaban: 10 mg, BID

PLUS

Enoxaparin Placebo

Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Name: BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A4

Apixaban: 5 mg, QD

PLUS

Enoxaparin Placebo

Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Name: BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A5

Apixaban: 10 mg, QD

PLUS

Enoxaparin Placebo

Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Name: BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A6

Apixaban: 20 mg, QD

PLUS

Enoxaparin Placebo

Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Name: BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Active Comparator: E1

Enoxaparin: 30 mg

PLUS

Apixaban Placebo

Drug: Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days
Drug: Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
Active Comparator: W1
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
Drug: Warfarin
Tablets, Oral, QD, 12 +/- 2 days

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097357

  Show 148 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00097357     History of Changes
Other Study ID Numbers: CV185-010
Study First Received: November 22, 2004
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and pulmonary embolism
Preventive therapy

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Warfarin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014