Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Inclusion criteria:

• Ischemic stroke with a brain lesion visualized by neuroimaging (either brain ComputedTomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is anon-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRIdiffusion-weighted images) in largest diameter if exclusivelysubcortical.Visualization by CT usually requires delayed imaging >24-48 hours afterstroke onset.

• The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months beforerandomization (mRS <=3 at randomization) in selected patients that are >= 60 yearsplus at least one additional risk factor for recurrent stroke.

• Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does notshow extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis inartery supplying the area of acute ischemia.

• As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection,there is absence of AF > 6 minutes in duration (within a 20 hour period, either assingle episode or cumulative time of multiple episodes). Further inclusion criteria apply.

Exclusion criteria:

• Modified Rankin Scale of >=4 at time of randomization or inability to swallowmedications.

• Major risk cardioembolic source of embolism such as: a) intracardiac thrombus asevidenced by transthoracic or transesophageal echocardiography, b) paroxysmal,persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prostheticcardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f)other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks)myocardial infarction, i) valvular vegetations, or j) infective endocarditis.

• Any indication that requires treatment with an anticoagulant as per Investigator`sjudgment.

• History of atrial fibrillation (unless it was due to reversible causes such ashyperthyroidism or binge drinking, and has been permanently resolved).

• Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection,migraine with aura/vasospasm, drug abuse).

• Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gaultequation) <30mL/min at screening, or where Investigator expects creatinine clearanceis likely to drop below 30mL/min during the course of the study. Further exclusion criteria apply.