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Embolic Stroke of Undetermined Source


A randomized, double-blind, evaluation of dabigatran etexilate taken twice daily compared to aspirin taken once daily for the prevention of stroke recurrence in subject with Embolic Stroke of Undetermined Source.


The purpose of this study is to test the benefit and safety of dabigatran etexilate 110 mg or 150 mg BID vs ASA 100 mg QD for secondary stroke prevention in patients with Embolic Stroke of Undetermined Source



Key Inclusion Criteria

  1. >60 years or 50-59 yrs plus at least 1 add’l risk factor for stroke:
    • Mild to mod Congestive Heart Failure (CHF) class <=3 w/LV EF < 40% as documented by echocardiogram, or angiogram in last 6 months
    • Diabetes Type 1 or 2
    • Hypertension requiring antihypertensive medication
    • Patient foramen ovale with no interventional occlusion planned
    • Prior stroke or Transient Ischemic Attack (TIA)
    • CHA2DS2-VASc (CHF, hypertension, Age >75 yrs, Diabetes, prior stroke/TIA) score >3
  2. Acute ischemic stroke with appropriate brain lesion visualized by neuroimaging either brain CT or MRI. The visualized stroke is non-lacunar infarct, ie. Involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical. It 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 (a-f above)
  3. 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
  4. As evidenced by cardiac monitoring for >24 hrs with automated rhythm detection, there is absence of atrial fibrillation (AF) > 6 minutes in duration (within a 24 hr period, either as single episode or cumulative over multiple episodes)
  5. The patient must give informed consent

Key Exclusion Criteria

  1. Modified Rankin Scale of >4 at time of randomization or inability to swallow medications
  2. Major risk cardioembolic source of embolism such as:
    • Intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography
    • Paroxysmal, persistent or permanent Atrial Fibrillation
    • Atrial flutter
    • Prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical)
    • Atrial myxoma
    • Other cardiac tumors
    • Moderate or severe mitral stenosis
    • Recent (<4 weeks) Myocardial Infarction (MI)
    • Valvular vegetations
    • Infective endocarditis
  3. Any indication that requires treatment with an anticoagulant as per Investigator’s judgment
  4. History of Atrial fibrillation (unless it was due to reversible causes and has been permanently resolved)
  5. Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse)
  6. Primary intracerebral hemorrhage on qualifying neuroimaging
  7. Conditions associated with increased risk of bleeding such as:
    • a. Major surgery in the previous month in which case the patient may be eligible when one month has passed
    • Planned major surgery or intervention in the next 3 months
    • History of intraocular, spinal, retroperitoneal or atraumatic Intra-articular bleeding unless the causative factor has been permanently eliminated or repaired per investigator judgment (eg. by surgery)
    • Gastrointestinal hemorrhage within the past six months unless the cause has been permanently eliminated or repaired per Investigator judgment (by surgery) or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
    • Hemorrhagic disorder or bleeding diathesis e.g. history of thrombocytopenia or platelet count <100,000/ml at screening, von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of prolonged bleeding after surgery/intervention
    • Fibrinolytic agents within 48 hours of study entry
    • Uncontrolled hypertension Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) > 100 mmHg)
  8. History of symptomatic nontraumatic intracranial hemorrhage
  9. Renal impairment with estimated CrCl (as calculated by Cockcroft-Gault equation ) < 30 mL/min at screening or where Investigator expects CrCl is likely to drop below 30 mL/min during the course of the study
  10. History of hypersensitivity or known contraindication to dabigatran etexilate or aspirin Identifier


Last Update


IRB Protocol Number
Principal Investigator(s)
Mathew Roller, MD

Clinical Trial Categories

  • Neurology
Renee Hendrickson, RN CCRC at 701-780-1694