Stroke Prevention Study Comparing the Efficacy and Safety of Pradaxa (Dabigatran) to Aspirin in Patients with Embolic Stroke of Undetermined Source (ESUS)

What we are studying

The purpose of this study is to determine the efficacy and safety of the drug Pradaxa (Dabigatran) compared to Aspirin in patients with Embolic Stroke of Undetermined Source (ESUS).

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

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 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.

What is involved

  • Diagnostics: 1. Brain CT or MRI 2. 12-lead ECG 3. Precordial or transesophageal echocardiography 4. Cardiac monitoring for > 20 hours 5. Imaging of both extracranial and intracranial arteries supplying the area of brain ischemia. Visits: 12 visits in Months 3; 6; 9; 12; 18; 24; and 30



Contact Information

Study Coordinator
Nancy Buchheimer

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.