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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01884337
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Anticoagulation Drug: Apixaban Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 24, 2015
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

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




Primary Outcome Measures :
  1. 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) ]

    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 :
  1. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884337


Locations
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India
Local Institution
Kozhikode, Kerala, India, 673008
Local Institution
Ahmedabad, India, 380015
Local Institution
Ahmedabad, India, 380016
Local Institution
Ahmedabad, India, 380060
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
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01884337     History of Changes
Other Study ID Numbers: CV185-158
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants