Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
Withdrawn
- Conditions
- Total Knee ReplacementTotal Hip ReplacementProphylaxis, Thromboembolism, Venous
- Interventions
- Registration Number
- NCT01523418
- Lead Sponsor
- Bayer
- Brief Summary
The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis
- Patients willing to give a written informed consent
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Exclusion Criteria
- Exclusion criteria must be read in conjunction with the local product information
- Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible.
- Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Rivaroxaban (Xarelto, BAY59-7939) -
- Primary Outcome Measures
Name Time Method Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events 3 months after the day of surgery Safety related variables are bleeding events reported as major or non-major adverse events 3 months after the day of surgery All cause mortality 3 months after the day of surgery
- Secondary Outcome Measures
Name Time Method