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

This study is not yet open for participant recruitment.

Verified April 2013 by Bayer

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01523418

First received: January 30, 2012

Last updated: April 18, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2012

Last Updated Date

April 18, 2013

Start Date ^ICMJE

May 2013

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01523418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients undergoing elective TKR / THR

Condition ^ICMJE

Prophylaxis, Thromboembolism, Venous
Total Knee Replacement
Total Hip Replacement

Intervention ^ICMJE

Drug: Rivaroxaban (Xarelto, BAY59-7939)

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)

Study Group/Cohort (s)

Group 1

Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT01523418

Other Study ID Numbers ^ICMJE

15871, XA1111IN

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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