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Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)

The objective of this study is to demonstrate that the efficacy of DE (110 mg b.i.d. or 150 mg b.i.d., with dosing according to age and renal function), is superior to ASA (100 mg once daily) for the prevention of stroke recurrence in patients with stroke of undetermined source. The trial will also characterize the safety of DE in this setting.

Phase

III

Recruitment Status

Past Studies