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news.Boehringer Ingelheim has enrolled the first patient in Phase III RE-SPECT ESUS trial designed to evaluate the efficacy and safety of dabigatran etexilate to prevent recurrent embolic stroke of undetermined source (ESUS).
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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.
In the Phase III RE-SPECT ESUS trial, the company intends to enroll around 6,000 patients in 35 countries.
Patients who experience an ESUS are at increased risk of another stroke and these recurrent strokes can lead to devastating consequences and are associated with high rates of morbidity and mortality.
The trial is designed to evaluate dabigatran etexilate compared to acetylsalicylic acid 100mg once daily for reduction of recurrent stroke.
During the trial, majority of patients will be given dabigatran etexilate 150mg twice daily, while patients aged 75 or older or who have moderate renal impairment (CrCl 30-50mL/min) will receive dabigatran etexilate 110mg twice daily.
The trial is part of the company’s extensive clinical trial program called RE-VOLUTION, which also includes the recently announced RE-CIRCUIT and RE-DUAL PCI studies and the entire program will involve more than 60,000 patients globally.