Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism
Phase of Trial: Phase III
Latest Information Update: 30 Oct 2017
At a glance
- Drugs Rivaroxaban (Primary) ; Aspirin
- Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism; Venous thrombosis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms EINSTEIN-CHOICE
- Sponsors Bayer
- 30 Oct 2017 According to a Janssen media release, based on the data from this trial the U.S. FDA approved the 10 mg once-daily dose of XARELTO (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy under a FDA Priority Review.
- 19 Oct 2017 According to a Janssen media release, based on the data from this trial, European Commission has granted the approval to update the label for its oral Factor Xa inhibitor Xarelto (rivaroxaban) XARELTO label to include the 10 mg once-daily dose in the European Union.
- 15 Sep 2017 Based on the data from this trial, the CHMP of the EMA has granted a positive opinion to update the label for its oral Factor Xa inhibitor Xarelto (rivaroxaban) to include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE) and the label update will apply to patients who have already received at least six months of standard anticoagulation therapy, as reported in a Bayer media release. The final European Commission decision is expected by November 2017.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History