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

A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

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 Overview

• Status: Completed
• Conditions: Anticoagulation
• Intervention / Treatment: Drug: Apixaban

• Study Type: Interventional
• Enrollment (Actual): 557
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380015
    • Local Institution
  • Ahmedabad, India, 380060
    • Local Institution
  • Ahmedabad, India, 380016
    • Local Institution
  • Alappuzha, India, 688005
    • Local Institution
  • Aurangabad, India, 431003
    • Local Institution
  • Bangalore, India, 560054
    • Local Institution
  • Chandigarh, India, 160012
    • Local Institution
  • Chennai, India, 600010
    • Local Institution
  • Delhi, India, 110029
    • Local Institution
  • Hyderabad, India, 500034
    • Local Institution
  • Kerala, India, 695011
    • Local Institution
  • Lucknow, India, 226003
    • Local Institution
  • Mohali, India, 160062
    • Local Institution
  • Mumbai, India, 400 022
    • Local Institution
  • Nagpur, India, 440003
    • Local Institution
  • Pune, India, 411001
    • Local Institution
  • Pune, India, 411004
    • Local Institution
  • Pune, India, 411005
    • Local Institution
  • Pune, India, 411013
    • Local Institution
  • Kerala
    • Kozhikode, Kerala, India, 673008
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apixaban (2.5 mg); Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects	Drug: Apixaban; Other Names: Eliquis; BMS-562247

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2015
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: CV185-158

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No