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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This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523418
First Posted: February 1, 2012
Last Update Posted: February 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 ]
  • Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events [ Time Frame: 3 months after the day of surgery ]
  • All cause mortality [ Time Frame: 3 months after the day of surgery ]

Enrollment: 0
Study Start Date: October 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523418


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01523418     History of Changes
Other Study ID Numbers: 15871
XA1111IN ( Other Identifier: Company Internal )
First Submitted: January 30, 2012
First Posted: February 1, 2012
Last Update Posted: February 4, 2016
Last Verified: February 2016

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
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants