Clinical Trials/NCT01523418

NCT01523418

Withdrawn

Not Applicable

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

Bayer0 sitesOctober 2014

ConditionsProphylaxis, Thromboembolism, Venous Total Knee Replacement Total Hip Replacement

InterventionsRivaroxaban (Xarelto, BAY59-7939)

DrugsRivaroxaban (Xarelto, BAY59-7939)

Overview

Phase: Not Applicable
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Prophylaxis, Thromboembolism, Venous
Sponsor: Bayer
Primary Endpoint: Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

November 2016

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Group 1

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Outcomes

Primary Outcomes

Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events

Time Frame: 3 months after the day of surgery

Safety related variables are bleeding events reported as major or non-major adverse events

Time Frame: 3 months after the day of surgery

All cause mortality

Time Frame: 3 months after the day of surgery

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