Safety & efficacy of Rivaroxaban in patients undergoing cardioversion

• Research type

  Research Study

• Full title

  A prospective, randomized, open-label, parallel-group, active-controlled, multicenter study exploring the efficacy and safety of once-daily oral rivaroxaban (BAY 59-7939) compared with that of dose-adjusted oral vitamin K antagonists (VKA) for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion

• IRAS ID

  109138

• Contact name

  Diana Gorog

• Eudract number

  2011-002234-39

• Research summary

  This study is designed to explore the efficacy and safety of rivaroxaban compared with that of dose-adjusted VKA for the prevention of stroke, transient ischemic attack (TIA - known as a mini-stroke), non-central nervous system (CNS) systemic embolism (a clot causing a partial or complete blockage of a vessel), myocardial infarction (MI, heart attack), and cardiovascular death in subjects with nonvalvular atrial fibrillation scheduled for cardioversion (re-setting of abnormal heart rhythm). Rivaroxaban is approved for use in patients with atrial fibrillation with a CHADS2 score of 1 or more for the prevention of stroke. However there is limited data assessing the efficacy of rivaroxaban in patients with AF who are undergoing cardioversion to restore normal sinus rhythm. This study aims to evaluate the safety and efficacy of rivaroxaban compared to standard care, namely vitamin K anatagonist (VKA) treatment, in patients with atrial fibrillation undergoing cardioversion.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/1285

• Date of REC Opinion

  30 Aug 2012

• REC opinion

  Further Information Favourable Opinion