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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01523418
First received: January 30, 2012
Last updated: June 21, 2013
Last verified: June 2013
  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:


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: September 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

Locations
India
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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: June 21, 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 April 15, 2014