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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01884337
First received: June 6, 2013
Last updated: May 6, 2015
Last verified: April 2015
  Purpose

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
Anticoagulation
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: May 2016
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01884337

Locations
India
Local Institution
Ahmedabad, India, 380015
Local Institution
Chandigarh, India, 160012
Local Institution
Lucknow, India, 226018
Local Institution
New Delhi, India, 110029
Local Institution
Pune, India, 411005
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01884337     History of Changes
Other Study ID Numbers: CV185-158
Study First Received: June 6, 2013
Last Updated: May 6, 2015
Health Authority: India: Drugs Controller General of India

ClinicalTrials.gov processed this record on May 21, 2015