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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: June 6, 2013
Last updated: July 26, 2016
Last verified: May 2016
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

Condition Intervention Phase
Drug: Apixaban
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary study endpoint is a composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding/clinically relevant non-major bleeding (CRNM) in subjects undergoing elective total knee or hip replacement [ Time Frame: Up to End of Treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects) ] [ Designated as safety issue: Yes ]

    ISTH major bleeding is;

    • Fatal or
    • Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or
    • 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;

    • Is clinically acute and overt
    • 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

    THR = Total hip replacement

    TKR = Total knee replacement

Secondary Outcome Measures:
  • Composite of VTE/all cause death, where VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism [ Time Frame: Up to end of treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: March 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01884337

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Contact: First line of the email MUST contain NCT# and Site #.

Local Institution Not yet recruiting
Kozhikode, Kerala, India, 673008
Contact: Site 0065         
Local Institution Not yet recruiting
Pune, Maharashtra, India, 422001
Contact: Site 0068         
Local Institution Recruiting
Ahmedabad, India, 380015
Contact: Site 0011         
Local Institution Not yet recruiting
Ahmedabad, India, 380016
Contact: Site 0067         
Local Institution Not yet recruiting
Chandigarh, India, 160012
Contact: Site 0040         
Local Institution Recruiting
Lucknow, India, 226018
Contact: Site 0026         
Local Institution Not yet recruiting
Mumbai, India, 400 022
Contact: Site 0066         
Local Institution Recruiting
New Delhi, India, 110029
Contact: Site 0052         
Local Institution Recruiting
Pune, India, 411005
Contact: Site 0062         
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01884337     History of Changes
Other Study ID Numbers: CV185-158 
Study First Received: June 6, 2013
Last Updated: July 26, 2016
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on August 24, 2016