Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement) (XYRIS)
February 2, 2016 updated by: Bayer
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients
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
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing elective TKR / THR
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
|
The treatment with Xarelto 10mg tablets should comply with the recommendations.
Rivaroxaban 10mg OD, 6-10 hours post-op, provided hemostasis has been achieved, for a period of 2 weeks (TKR) & 5 weeks (THR)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety related variables are bleeding events reported as major or non-major adverse events
Time Frame: 3 months after the day of surgery
|
3 months after the day of surgery
|
|
Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
Time Frame: 3 months after the day of surgery
|
3 months after the day of surgery
|
|
All cause mortality
Time Frame: 3 months after the day of surgery
|
3 months after the day of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
November 1, 2016
Study Completion (Anticipated)
November 1, 2016
Study Registration Dates
First Submitted
January 30, 2012
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimate)
February 1, 2012
Study Record Updates
Last Update Posted (Estimate)
February 4, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15871
- XA1111IN (Other Identifier: Company Internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.