First trial of a novel oral anticoagulant starts in prevention of recurrent stroke due to a blood clot of undetermined source

Boehringer Ingelheim announces that the first patient has been enrolled in the RE-SPECT ESUS™ phase III study to investigate the efficacy and safety of dabigatran etexilate for the prevention of recurrent Embolic Stroke of Undetermined Source, also called ESUS. An 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.^4,6 RE-SPECT ESUS™ aims to include 6,000 patients in 35 countries.⁵

Patients who experience an embolic stroke of undetermined source, an ESUS, are at increased risk of another stroke.^1–3 These recurrent strokes can lead to potentially devastating consequences and are associated with high rates of morbidity and mortality.¹ The currently available treatment options to prevent recurrent stroke following ESUS offer only limited efficacy.⁴ There is also limited knowledge and data available to guide treatment decisions in these patients, resulting in a considerable unmet need.³

Professor Hans-Christoph Diener, Professor of Neurology and Chairman of the Department of Neurology, 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. These patients are at high risk of a recurrent embolic stroke. Embolic strokes of undetermined sources make up a quarter of all strokes and are caused by blood clots, which travel into the brain via large blood vessels. 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™ study (Randomized Evaluation in Secondary stroke PrEvention Comparing the Thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid (ASA) in Embolic Stroke of Undetermined Source) aims to include 6,000 patients from study sites in Asia, Europe, North and South America. It is part of Boehringer Ingelheim’s extensive clinical trial programme, RE-VOLUTION™. Also including the recently announced RE-CIRCUIT™ and RE-DUAL PCI™ studies, the entire programme will involve over 60,000 patients globally.⁵

References

1. Hankey GJ et al. Long-Term Disability After First-Ever Stroke and Related Prognostic Factors in the Perth Community Stroke Study, 1989–1990 Stroke. 2002;33:1034–40.
2. Mohr JP, et al. A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke. N Engl J Med. 2001;345:1444–51.
3. Bang OY, et al. Frequency and mechanisms of stroke recurrence after cryptogenic stroke. Ann Neurol. 2003;54:227–34.
4. Hart RG, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014;13:429–38.
5. Boehringer Ingelheim. Data on File.
6. National Stroke Association “Ischemic Stroke” Available at: http://www.stroke.org/understand-stroke/what-stroke/ischemic-stroke Last accessed December 2014.