Xarelto is indicated for the prevention of stroke and systemic embolism in eligible adult patients with non-valvular atrial fibrillation with one or more risk factors such as: congestive heart failure, hypertension, age≥75 years, diabetes mellitus and prior stroke or transient ischaemic attack.
Bayer HealthCare has announced the initiation of two new studies investigating its once-daily, oral anticoagulant Xarelto® (rivaroxaban) in patients with AF who are scheduled for cardioversion or first catheter ablation.
X-VeRT 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 United Kingdom. The study will further examine the efficacy and safety profile of Xarelto to prevent cardiovascular events, including stroke, in comparison to dose-adjusted vitamin K antagonist (VKA).
VENTURE-AF will evaluate the safety profile of Xarelto 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 proven to be effective in preventing stroke and non-CNS (central nervous system) systemic embolism in patients with non-valvular AF. Importantly, in ROCKET AF, patients treated with rivaroxaban were associated with significantly fewer major bleeding events, namely intracranial haemorrhages and fatal bleeds, when compared with warfarin, although GI bleeding did occur more commonly with rivaroxaban than with warfarin. Additionally, in the study, rivaroxaban did not demonstrate any increase in myocardial infarctions.
Cardioversion and Catheter Ablation
Cardioversion and catheter ablation are therapies commonly used to restore normal heart rhythm in patients with AF, but can cause pre-existing blood clots to dislodge and travel to the brain, causing a stroke.
Currently, the majority of patients undergoing these procedures receive VKAs such as warfarin to prevent blood clots. However, VKAs have a narrow therapeutic window and are associated with unpredictable levels of anticoagulation, which can leave patients at risk.
“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.”
About the X-VeRT Study
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 a Phase IIIb prospective, randomised, open-label, parallel-group, active-controlled, multi-centre study of 1,500 patients with non-valvular AF cardioversion. Patients from Africa, Asia, Europe, North America and South America are expected to be included. The study is designed to explore the efficacy and safety of once-daily oral rivaroxaban, 20 mg, (15 mg for patients with moderate renal impairment) in comparison to dose-adjusted VKA for the prevention of cardiovascular events including stroke, transient ischemic attack (TIA), non-CNS systemic embolism, myocardial infarction (MI), and cardiovascular death.
About the VENTURE-AF Study
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) is a Phase IIIb randomised, open-label, active-controlled study in 200 patients with paroxysmal (occasional) or persistent non-valvular AF undergoing first catheter ablation. Patients from Europe and North America are expected to be included. The study is designed to evaluate the safety profile of uninterrupted once-daily oral rivaroxaban 20 mg in comparison to uninterrupted VKA or the dual drug approach of VKA plus low molecular weight heparin for patients with non-valvular AF undergoing first catheter ablation.
About Atrial Fibrillation (AF)
Atrial Fibrillation is the most common sustained cardiac rhythm disorder and affects 750,000 people in the UK1. It increases the risk of stroke by up to five times1, the effects of which can be devastating and include severe disability and death. An estimated 14% of all strokes are caused by AF2 and over 12,500 strokes in the UK are directly linked to the condition.2
About Xarelto® (Rivaroxaban)
Rivaroxaban is an oral anticoagulant that was discovered in Bayer HealthCare’s Pharmaceuticals’ Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. It has a rapid onset of action with a predictable dose response and high bioavailability when taken with food, no requirement for routine coagulation monitoring, as well as a lower potential for food and drug interactions than warfarin. Like other anticoagulants, rivaroxaban may cause bleeding which may potentially be life threatening.
Rivaroxaban is the most broadly-indicated novel oral anticoagulant, approved in the UK for the prevention and treatment of venous and arterial thromboembolic (VAT) disorders across multiple acute and chronic conditions including stroke prevention in AF.
Rivaroxaban is marketed under the brand name Xarelto® for the prevention of stroke in eligible adult patients with non-valvular atrial fibrillation, the treatment of deep vein thrombosis (DVT), prevention of recurrent DVT and pulmonary embolism (PE), and for VTE prevention in adult patients following elective hip or knee replacement surgery. Rivaroxaban is approved in more than 120 countries worldwide and to date has been successfully launched in more than 85 countries by Bayer HealthCare Pharmaceuticals in its original indication of VTE prevention.
In May 2012, the National Institute for Health and Clinical Excellence (NICE) recommended Xarelto for NHS use for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors.3 The guidance advised that the drug should be considered as a therapeutic option in non-valvular AF patients with one or more stroke risk factors, such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, and prior stroke or transient ischaemic attack (TIA).
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC.
Source: Bayer HealthCare