Date: 2015-01-27
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
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)
Product: rivaroxaban
Action
mechanism: anticoagulant agent/oral direct Factor Xa inhibitor
Disease: embolic stroke of undetermined source
Therapeutic
area: Cardiovascular diseases
Country: Belgium, Brazil, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Republic of Korea, Mexico, Portugal, Russian Federation, South Africa, Spain, Switzerland, UK, USA
Trial
details:
- 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. (NCT02313909)
Latest
news:
- • On January 27, 2015, Bayer HealthCare, in partnership with its development partner Janssen Research & Development, LLC, 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 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.
Is
general: Yes
