Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

557 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-24

Study Completion Date

2018-06-04

Brief Summary

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The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement

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Detailed Description

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Conditions

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Anticoagulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apixaban (2.5 mg)

Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Other Intervention Names

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Eliquis BMS-562247

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative
* Active bleeding or at high risk for bleeding.
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery
* Active hepatobiliary disease
* Hemoglobin \<9 g/dL
* Platelet count \<100,000/mm3
* Creatinine clearance \<30 mL/min

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No