Bayer announced the preliminary results of the pivotal Phase III ROCKET AF study of rivaroxaban, the full details of which will be presented at the Late Breaker Session on November 15, 2010, at the Scientific Sessions of the American Heart Association (AHA) in Chicago, USA.
The primary objective of the study was to establish the non-inferiority of 20 mg rivaroxaban once-daily (or 15 mg in patients with moderate renal impairment at screening) compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF) at risk of stroke and non-CNS systemic embolism. The primary efficacy endpoint was a composite of all-cause stroke and non-CNS systemic embolism. The primary safety endpoint was the composite of major and non-major clinically relevant bleeding events.
Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted warfarin. The rates of the composite of major and non-major clinically relevant bleeding were comparable.
ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) was an event-driven, prospective, randomized, double-blind Phase III study in which more than 14,000 patients have been enrolled from more than 1,100 centers across 45 countries worldwide. The study was led by the Duke Clinical Research Institute, Durham, North Carolina, USA, and an international academic executive committee.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.