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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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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