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news.Bayer HealthCare along with its partner Janssen Research & Development has entered into a collaboration with the Population Health Research Institute (PHRI) and the Canadian Stroke Prevention Intervention Network (C-SPIN) to carry out a Phase III NAVIGATE ESUS study in patients with a recent embolic stroke of undetermined source (ESUS).
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The randomized double-blind, event-driven superiority trial is designed to examine the benefits of the once-daily, oral Factor Xa Inhibitor, rivaroxaban in these patients.
Around 7,000 patients will be enrolled in the trial at 350 sites, across more than 25 countries worldwide.
NAVIGATE ESUS is a Phase III study of secondary prevention of stroke and prevention of systemic embolism in these patients.
The trial’s primary efficacy outcome is the composite of the first occurrence of all recurrent strokes and systemic embolism, while the primary safety outcome is modified ISTH major bleeding.
In the trial, patients will be given either rivaroxaban 15mg once daily or acetylsalicylic acid (ASA) 100mg once daily.
Bayer HealthCare member of the Executive Committee and head of Global Development Dr Joerg Moeller said: "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.
"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."
Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.