Bayer launches major new stroke trial
pharmafile | January 27, 2015 | News story | Research and Development, Sales and Marketing | Bayer, Canadian Stroke Prevention Intervention Network, Population Health Research Institute, Xarelto, rivaroxaban, stroke
Bayer is enrolling more than 7,000 people in a trial to test whether its blood-thinning drug Xarelto can successfully prevent strokes from recurring.
The German company has announced it will work with development partner Johnson & Johnson, along with two Canadian research institutes: the Population Health Research Institute (PHRI) and the Canadian Stroke Prevention Intervention Network.
The Phase III trial – the NAVIGATE-ESUS study – will investigate the benefits of the anticoagulant Xarelto (rivaroxaban) in around 7,000 patients who have had a recent embolic stroke of undetermined source (ESUS).
This will be a secondary prevention trial – looking at whether taking Xarelto once a day will prevent a second stroke or blood clot – and will compare Xarelto to once-daily aspirin.
In the UK Xarelto is licensed for the prevention of venous thromboembolism, stroke, systemic embolism and blood clots. In January the UK healthcare guidance body NICE recommended Xarelto for the prevention of clots in patients after an acute coronary syndrome in final draft guidance.
Xarelto has registered strong worldwide sales, and has contributed to a 10% boost in Johnson & Johnson sales in the last quarter of 2014.
An estimated 300,000 people have an embolic stroke of unknown cause in North America and Europe every year, and this type of stroke accounts for approximately 25% of all ischaemic strokes.
Dr Joerg Moeller, Bayer head of global development, says: “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.”
Lilian Anekwe
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