Overview

Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

Status:
Withdrawn
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Rivaroxaban
Criteria
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

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