Status:
WITHDRAWN
Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
Lead Sponsor:
Bayer
Conditions:
Prophylaxis, Thromboembolism, Venous
Total Knee Replacement
Eligibility:
All Genders
18+ years
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
Eligibility Criteria
Inclusion
- Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis
- Patients willing to give a written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01523418
Start Date
October 1 2014
End Date
November 1 2016
Last Update
February 4 2016
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