BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery - Full Text View

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:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Knee Replacement Pulmonary Embolism

Drug Information available for: Warfarin Warfarin sodium Apixaban Enoxaparin sodium

U.S. FDA Resources

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

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:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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 May 16, 2013