Trial Condition(s):
Prophylaxis, Thromboembolism, Venous, Total Knee Replacement
Study to observe safety of Xarelto in VTE prophlylaxis after elective TKR (Total Knee Replacement) or THR (Total Hip Replacement) (XYRIS)
Bayer Identifier:
15871
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Terminated/Withdrawn
Trial Purpose
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
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
Trial Summary
Enrollment Goal
0
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
Trial Design
Xarelto in the prophylaxis of post surgical venous thromboembolism after elective major orthopedic surgery or hip or knee in Indian patients
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Safety related variables are bleeding events reported as major or non-major adverse eventsTimeframe: 3 months after the day of surgery
- Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse eventsTimeframe: 3 months after the day of surgery
- All cause mortalityTimeframe: 3 months after the day of surgery
Additional Information
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