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

Total Knee Replacement Clinical Trial

— XYRIS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01523418
• Other study ID #: 15871
• Secondary ID: XA1111IN
• Status: Withdrawn
• Phase: N/A
• First received: January 30, 2012
• Last updated: February 2, 2016
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prophylaxis, Thromboembolism, Venous
• Thromboembolism
• Total Hip Replacement
• Total Knee Replacement
• Venous Thromboembolism

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety related variables are bleeding events reported as major or non-major adverse events		3 months after the day of surgery	Yes
Primary	Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events		3 months after the day of surgery	Yes
Primary	All cause mortality		3 months after the day of surgery	Yes

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