Embolic stroke of undetermined source (ESUS), is a type of ischemic stroke where, despite testing, the cause of the blood clot causing the blockage is not identifiable. Subjects who experience a stroke due to a clot are at risk for another stroke. The majority of these subjects require lifelong treatment with a blood thinning medication to reduce the risk of another stroke.
It is unclear how best to prevent another stroke in subjects with ESUS. These subjects are often given one or more antiplatelet drugs such as acetylsalicylic acid, clopidogrel and/or ticlopidine. However, for subjects with ESUS these treatments are given based on limited data.
Because it is thought that the cause of an ESUS is due to a clot forming, it is thought that subjects with ESUS should be treated the same as subjects with other risks for stroke (due to clot forming). The purpose of this study is then to test the safety and effectiveness of the anticoagulant dabigatran etexilate taken twice daily compared to aspirin [acetylsalicylic acid (Acetylsalicyls