Date: 2015-01-27
Type of information: Clinical research agreement
Compound: rivaroxaban
Company: Bayer Healthcare (Germany) Janssen R&D, a J&J company (USA - NJ) Population Health Research Institute (PHRI) (Canada) Canadian Stroke Prevention Intervention Network (C-SPIN) (Canada)
Therapeutic area: Cardiovascular diseases
Type agreement: clinical research
Action mechanism:
Disease: embolic stroke of undetermined source
Details: * On January 27, 2015, Bayer HealthCare, in partnership with its development partner Janssen Research & Development, announced a collaboration with the Population Health Research Institute (PHRI) and the Canadian Stroke Prevention Intervention Network (C-SPIN) to conduct the global Phase III NAVIGATE ESUS study. The study will investigate the benefits of the once-daily, novel oral anticoagulant rivaroxaban in approximately 7,000 patients with a recent embolic stroke of undetermined source (ESUS). Enrollment of patients for the study has started successfully. \"The ROCKET AF study confirmed that once-daily rivaroxaban is highly effective in preventing stroke in patients with non-valvular atrial fibrillation, with and without previous stroke or transient ischaemic attack, so we believe there is potential for rivaroxaban to provide a similar protective benefit to patients with a recent ESUS,\" said Dr Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. \"Rivaroxaban is already approved to prevent and treat more venous and arterial thromboembolic conditions than any other novel oral anticoagulant, and it has the potential to benefit even more patients at risk of the serious and often life-threatening conditions caused by blood clots.\" The NAVIGATE ESUS study will contribute important knowledge to the extensive evaluation of rivaroxaban, a program that - by the time of its completion - is expected to include more than 275,000 patients in both clinical trials and real world settings. NAVIGATE ESUS is a randomised double-blind, event-driven superiority Phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent embolic stroke of undetermined source (ESUS). The study will include approximately 7,000 patients from 350 sites, across more than 25 countries worldwide. The primary efficacy outcome is the composite of the first occurrence of all recurrent strokes (ischaemic, hemorrhagic, and undefined stroke, and transient ischaemic attack (TIA) with positive neuroimaging) and systemic embolism. The primary safety outcome is modified ISTH major bleeding. Patients will be randomised to receive either rivaroxaban 15mg once daily or acetylsalicylic acid (ASA) 100mg once daily.
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