Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Condition: Stroke; Secondary Prevention
MeSH terms: Neoplasm Metastasis; Stroke; Embolic Stroke
Intervention: optional ASA as comedication; placebo to ASA; placebo to optional ASA as comedication; placebo to dabigatran etexilate; ASA 100 mg; dabigatran etexilate
Intervention description: optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.; placebo to comparator drug; optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.; placebo; active comparator drug; active drug
Intervention MeSH terms: Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5390.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No

Summary:

      This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown
      source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1
      ratio) and have visits every three months. The study doctor may prescribe blinded concomitant
      ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs),
      Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when
      the required number of stroke events are positively adjudicated which is estimated to take 3
      years (including 2.5 years of enrollment).
    

Eligibility criteria:

        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 Transcranial Doppler (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 Atrial fibrillation (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.