New trial will assess dabigatran for prevention of recurrent stroke

The first patient has been enrolled in the RE-SPECT ESUS study, which will investigate the safety of dabigatran etexilate for the prevention of recurrent embolic stroke of undetermined source, according to a press release from Boehringer Ingelheim.

The randomized, double blind, placebo-controlled trial will comparedabigatran (Pradaxa, Boehringer Ingelheim) 110 mg or 150 mg twice daily vs. acetylsalicylic acid 100 mg once daily.

The primary outcome is time to first recurrent stroke.  Secondary outcomes include time to ischemic stroke; a composite endpoint of time to nonfatal stroke, nonfatal MI and CV death; and time to all-cause mortality.

Anticipated enrollment is 6,000 patients in 35 countries. The trial is slated for end in November 2017, according to the release.

 “Embolic strokes of undetermined sources make up a quarter of all strokes. … We look forward to investigating whether dabigatran etexilate can be a treatment alternative for these patients compared to the present standard of care, which is acetylsalicylic acid,” Hans-Christoph Diener, MD, PhD,professor of neurology and chairman of the department of neurology at the University of Essen, Germany, said in the release.

RE-SPECT ESUS is part of Boehringer Ingelheim’s RE-VOLUTION clinical trial program.

Source: www.healio.com