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 Computed
Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a
non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI
diffusion-weighted images) in largest diameter if exclusively
subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after
stroke 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 before
randomization (mRS <=3 at randomization) in selected patients that are >= 60 years
plus at least one additional risk factor for recurrent stroke.

- Arterial imaging or cervical plus TCD ultrasonography does not show extra-cranial or
intracranial atherosclerosis with >= 50% luminal stenosis in artery 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 as
single 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 swallow
medications.

- Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as
evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal,
persistent or permanent AF, c) atrial flutter, d) prosthetic cardiac 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`s
judgment.

- History of atrial fibrillation (unless it was due to reversible causes such as
hyperthyroidism 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-Gault
equation) <30mL/min at screening, or where Investigator expects creatinine clearance
is likely to drop below 30mL/min during the course of the study.

Further exclusion criteria apply.