First trial of oral anticoagulant to prevent recurrent stroke due to a blood clot of undetermined source


The first patient has been enrolled in the RE-SPECT ESUS phase III study to investigate the efficacy and safety of dabigatran etexilate (Boehringer Ingelheim) for the prevention of recurrent embolic stroke of undetermined source (ESUS). RE-SPECT ESUS aims to include 6,000 patients in 35 countries.

Patients who experience an ESUS are at increased risk of another stroke. These recurrent strokes can lead to potentially devastating consequences and are associated with high rates of morbidity and mortality. The currently available treatment options to prevent recurrent stroke following ESUS offer only limited efficacy. There is also limited knowledge and data available to guide treatment decisions in these patients, resulting in a considerable unmet need.

Professor Hans-Christoph Diener, professor of neurology and chairman of the Department of Neurology, University of Essen, Germany, says: “This trial investigates the safety and efficacy profile of dabigatran etexilate versus acetylsalicylic acid in patients with embolic strokes of undetermined source. These patients are at high risk of a recurrent embolic stroke. Embolic strokes of undetermined sources make up a quarter of all strokes and are caused by blood clots, which travel into the brain via large blood vessels.”

Boehringer Ingelheim hopes that the RE-SPECT ESUS (Randomised evaluation in secondary stroke prevention comparing the thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid in embolic stroke of undetermined source) study aims to include 6,000 patients from study sites in Asia, Europe, North and South America. It is part of Boehringer Ingelheim’s clinical trial programme, RE-VOLUTION. Also including the recently announced RE-CIRCUIT and RE-DUAL PCI studies, the entire programme will involve over 60,000 patients globally.