Phase 4
Completed N=498
Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Anticoagulation
Source: ClinicalTrials.gov NCT01884337 ↗
Enrolled (actual)
498
Serious AEs
0.4%
Results posted
Sep 2019
Primary outcomePrimary: 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 — 0; 0; 0; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days |
1; 1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01884337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.