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

Bristol-Myers Squibb557 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

557

Conditions

Anticoagulation

Interventions

ApixabanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Local Institution

Kozhikode, Kerala, India

Local Institution

Ahmedabad, India

Local Institution

Outcomes

Primary Outcomes

Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days

TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours. CRNM bleeding is bleeding that 1\) Is clinically acute and overt 2) Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis

Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Secondary Outcomes

Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days

VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.

Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Data from ClinicalTrials.gov

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