Boehringer Ingelheim has started patient enrolment in the RE-SPECT ESUS Phase III trial designed to evaluate the efficacy and safety of dabigatran etexilate to prevent recurrent embolic stroke of undetermined source (ESUS).
ESUS occurs when a blood clot from somewhere in the body blocks a blood vessel in the brain and the source of this blood clot is unknown.
The company intends to enrol around 6,000 patients in 35 countries in the Phase III RE-SPECT ESUS trial.
Patients who experience an ESUS are at increased risk of another stroke and these recurrent strokes can lead to potentially devastating consequences and are associated with high rates of morbidity and mortality.
The existing treatment options to prevent recurrent stroke following ESUS offer only limited efficacy, while there is also limited knowledge and data available to guide treatment decisions in these patients, resulting in a considerable unmet need.
University of Essen professor of Neurology and chairman of the Department of Neurology Hans-Christoph Diener said: "We are delighted to report that the first patient was randomised. This trial investigates the safety and efficacy profile of dabigatran etexilate versus acetylsalicylic acid in patients with embolic strokes of undetermined source.
"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."
The RE-SPECT ESUS trial will evaluate dabigatran etexilate compared to acetylsalicylic acid 100mg once daily for reduction of recurrent stroke.
During the trial, majority of patients will receive dabigatran etexilate 150mg twice daily, while patients aged 75 or older or who have moderate renal impairment (CrCl 30-50mL/min) will be given dabigatran etexilate 110mg twice daily.
The trial is part of the company's extensive clinical trial programme RE-VOLUTION, which also includes the recently announced RE-CIRCUIT and RE-DUAL PCI studies.