BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pulmonary Embolism; Venous Thrombosis

Treatments: Drug: Apixaban; Drug: Apixaban Placebo; Drug: Enoxaparin; Drug: Enoxaparin Placebo; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097357

CV185-010

Details and patient eligibility

About

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.

Enrollment: 1,238 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,238 participants in 8 patient groups

A1

Experimental group

Description:

Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo

Treatment:

Drug: Enoxaparin Placebo

Drug: Apixaban

A2

Experimental group

Description:

Apixaban: 5 mg, BID PLUS Enoxaparin Placebo

Treatment:

Drug: Enoxaparin Placebo

Drug: Apixaban

A3

Experimental group

Description:

Apixaban: 10 mg, BID PLUS Enoxaparin Placebo

Treatment:

Drug: Enoxaparin Placebo

Drug: Apixaban

A4

Experimental group

Description:

Apixaban: 5 mg, QD PLUS Enoxaparin Placebo

Treatment:

Drug: Enoxaparin Placebo

Drug: Apixaban

A5

Experimental group

Description:

Apixaban: 10 mg, QD PLUS Enoxaparin Placebo

Treatment:

Drug: Enoxaparin Placebo

Drug: Apixaban

A6

Experimental group

Description:

Apixaban: 20 mg, QD PLUS Enoxaparin Placebo

Treatment:

Drug: Enoxaparin Placebo

Drug: Apixaban

E1

Active Comparator group

Description:

Enoxaparin: 30 mg PLUS Apixaban Placebo

Treatment:

Drug: Enoxaparin

Drug: Apixaban Placebo

W1

Active Comparator group

Description:

Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0

Treatment:

Drug: Warfarin