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

INGELHEIM, Germany - Monday, December 15th 2014 [ME NewsWire]

    First patient enrolled in RE-SPECT ESUSTM, which evaluates dabigatran in prevention of recurrent Embolic Stroke of Undetermined Source (ESUS)
    Patients who suffer an ESUS are at high risk of another fatal or disabling stroke due to lack of effective treatment options1–4
    RE-SPECT ESUSTM aims to close gaps in clinical data and knowledge on prevention of recurrent ESUS
    RE-VOLUTIONTM clinical study programme for dabigatran encompasses 60,000 patients5

(BUSINESS WIRE) - For Non-US/Non-UK/Non-Canadian Media

Boehringer Ingelheim announces that the first patient has been enrolled in the RE-SPECT ESUSTM 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 ESUSTM 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 ESUSTM 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-VOLUTIONTM. Also including the recently announced RE-CIRCUITTM and RE-DUAL PCITM studies, the entire programme will involve over 60,000 patients globally.5

~ENDS~                                   

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/15_december_2014_dabigatranetexilate.html

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Friederike Middeke

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Fax: +49 6132 – 77 6601

Email: press@boehringer-ingelheim.com

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