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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 May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01523418
First received: January 30, 2012
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  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


Condition Intervention
Prophylaxis, Thromboembolism, Venous
Total Knee Replacement
Total Hip Replacement
 Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients

Resource links provided by NLM:

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing elective TKR / THR

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523418

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
India
Not yet recruiting
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01523418     History of Changes
Other Study ID Numbers: 15871, XA1111IN
Study First Received: January 30, 2012
Last Updated: May 17, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Bayer:
Xarelto
Thromboembolism, Venous
Orthopedic surgery
Factor Xa inhibitor
Observational study

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 23, 2013