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Clinical Articles, News & Views

Two new rivaroxaban studies announced

Two new studies have been launched to investigate rivaroxaban (Xarelto®, Bayer HealthCare) in patients with atrial fibrillation (AF) who are scheduled for cardioversion or first catheter ablation.

X-VeRT (EXplore the efficacy and safety of once-daily oral riVaroxaban for the prEvention of caRdiovascular events in subjects with non-valvular aTrial fibrillation scheduled for cardioversion) is the largest randomised study dedicated to evaluating patients with AF scheduled for cardioversion.

It will include approximately 1,500 patients across 17 countries worldwide, including the UK. The study will further examine the efficacy and safety profile of rivaroxaban to prevent cardiovascular events, including stroke, in comparison to dose-adjusted vitamin K antagonist (VKA).

VENTURE-AF (A Randomised, Open-label, Active-controlled Multi-centre Study to Evaluate the Safety of Rivaroxaban and Vitamin K Antagonists in Subjects Undergoing Catheter Ablation for Atrial Fibrillation) will evaluate the safety profile of rivaroxaban in patients with non-valvular AF undergoing first catheter ablation, in 200 patients across five countries, including the UK.

X-VeRT and VENTURE-AF complement the Phase III ROCKET AF study, where once-daily rivaroxaban was shown to be effective in preventing stroke and non-central nervous system systemic embolism in patients with non-valvular AF. In ROCKET AF, patients treated with rivaroxaban were associated with significantly fewer major bleeding events when compared with warfarin, although gastrointestinal bleeding did occur more commonly with rivaroxaban than with warfarin. Additionally, in the study, rivaroxaban did not demonstrate any increase in myocardial infarction.

“Patients with atrial fibrillation scheduled for cardioversion or ablation therapy are at a heightened risk of stroke both pre and post-treatment, and require optimal protection from dangerous blood clots,” said Professor John Camm, St George’s University Hospital, London. “These two studies will add to our understanding of the potential of rivaroxaban to prevent potentially devastating outcomes in the broadest possible range of patients.”

Published on: August 24, 2012

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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