Boehringer Ingelheim commences new Pradaxa stroke trial

Boehringer Ingelheim has announced the commencement of a new clinical trial of Pradaxa, assessing the novel oral anticoagulant as a stroke prevention aid.

The phase III RE-SPECT ESUS study will investigate the efficacy and safety of the dabigatran etexilate-based therapy for the prevention of recurrent embolic stroke of undetermined source, also known as ESUS.

An ESUS occurs when a blood clot from an unknown part of the body blocks a blood vessel in the brain. Patients who suffer such an event are at elevated risk of another stroke, leading to potentially devastating health consequences.

The first patient has now been enrolled for RE-SPECT ESUS, which aims to include 6,000 patients in 35 countries. It will help to close gaps in clinical data and knowledge on the prevention of recurrent ESUS.

Professor Hans-Christoph Diener, professor of neurology and chairman of the department of neurology at the University of Essen, said: "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."

Pradaxa has been approved in more than 100 countries and has accrued more than two million patient-years of experience in all licensed indications globally.