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Completed

NCT Number: NCT00097357

BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Local Institution, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Tablets, Oral, 12 +/- 2 days

Other names: BMS-562247

Enoxaparin

Drug

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

Warfarin

Drug

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

Enoxaparin Placebo

Drug

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

Apixaban Placebo

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 23, 2004
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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