Terminated/Withdrawn

Prophylaxis, Thromboembolism, Venous, Total Knee Replacement, Total Hip Replacement

Bayer Identifier:

15871

ClinicalTrials.gov Identifier:

NCT01523418

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to observe safety of Xarelto in VTE prophlylaxis after elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

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

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial Dates

October 2014 - November 2016

Phase

N/A

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn		Many Locations, India

Primary Outcome

Safety related variables are bleeding events reported as major or non-major adverse events
Time Frame:
3 months after the day of surgery
Safety Issue:
Yes
Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
Time Frame:
3 months after the day of surgery
Safety Issue:
Yes
All cause mortality
Time Frame:
3 months after the day of surgery
Safety Issue:
Yes

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

N/A

Additional Information

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