Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
NCT01884337
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
- 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
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Descriptive Information | |||||
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Brief Title ICMJE | Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery | ||||
Official Title ICMJE | 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 | ||||
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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Anticoagulation | ||||
Intervention ICMJE | Drug: Apixaban
Other Names:
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Study Arms ICMJE | 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 Intervention: Drug: Apixaban | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 557 | ||||
Original Estimated Enrollment ICMJE | 750 | ||||
Actual Study Completion Date ICMJE | June 4, 2018 | ||||
Actual Primary Completion Date | June 4, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | India | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01884337 | ||||
Other Study ID Numbers ICMJE | CV185-158 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Bristol-Myers Squibb | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | ||||
Verification Date | November 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |