Boehringer Ingelheim Enrolls Patients In Dabigatran Trial For Stroke

Boehringer Ingelheim has enrolled its first patient in a Phase 3 study of dabigatran etexilate (brand name Pradaxa) to prevent recurrent Embolic Stroke of Undetermined Source (ESUS). The company announced the trial initiation in a press release, stating that the RE-SPECT ESUS trial will evaluate 6,000 patients in 35 countries. Investigators intend to add to the clinical evidence on the disease and define how dabigatran prevents stroke. Professor Hans-Christoph Diener, Professor at the University of Essen, Germany, said, “We are delighted to report that the first patient was randomized. This trial investigates the safety and efficacy profile of dabigatran etexilate versus acetylsalicylic acid in patients with embolic strokes of undetermined source.”

Dabigatran Etexilate

Pradaxa (dabigatran etexilate) is approved in over 100 countries and has been on the market for over six years for the prevention of stroke, systemic embolism, and venous thromboembolic events. The agent is a direct thrombin inhibitor (DTI), part of a new class of oral anticoagulants. Pradaxa blocks thrombin activity, has low drug-drug interaction activity, and does not require routine monitoring. The Food and Drug Administration (FDA) recently reported on a long-term safety study of Pradaxa compared to warfarin. The federal agency found that Pradaxa showed a favorable benefit/risk profile and performed better than Warfarin in reducing intracranial hemorrhage, ischemic stroke, and death.

RE-SPECT ESUS Study

Boehringer Ingelheim’s RE-SPECT ESUS study (Randomized Evaluation in Secondary stroke PrEvention Comparing the Thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid (ASA) in Embolic Stroke of Undetermined Source) will evaluate patients in Asia, Europe, North America, and South America. The study is part of the company’s RE-VOLUTION clinical trial program, which includes the RE-CIRCUIT and RE-DUAL PCI studies.

The new trial will evaluate dabigatran etexilate vs. the current standard of care, acetylsalicylic acid, once daily. Most patients will receive dabigatran etexilate twice daily for six months up to three years. Patient outcomes will be assessed after treatment ends.

ESUS Strokes

Patients who experience an ESUS stroke are likely to suffer another stroke. Recurring strokes significantly increase the patient’s risk of mortality. Boehringer Ingelheim states that data and knowledge on the condition is limited, and current treatments only offer limited efficacy.