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 18, 2014
Last verified: June 2014

January 30, 2012
June 18, 2014
October 2014
November 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01523418 on ClinicalTrials.gov Archive Site
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Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients undergoing elective TKR / THR

  • Prophylaxis, Thromboembolism, Venous
  • Total Knee Replacement
  • Total Hip Replacement
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)
Group 1
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
500
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01523418
15871, XA1111IN
No
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

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