title: Design of Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS).
abstract: BACKGROUND
  Cryptogenic ischemic strokes constitute 20-30% of ischemic strokes, the majority of which are embolic strokes of undetermined source. The standard preventive treatment in these patients is usually acetylsalicylic acid.
  
  
  OBJECTIVE
  The Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS) is designed to determine whether the oral thrombin inhibitor dabigatran, taken within three-months after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of recurrent stroke and to characterize the safety of dabigatran in this setting.
  
  
  METHODS
  Prospective, randomized, double-blind, multicenter trial in approximately 6000 patients and 550 centers with embolic stroke of undetermined source. Subjects are randomized to dabigatran or acetylsalicylic acid and treated for an expected minimum of six-months and up to approximately three-years. It is an event-driven trial aiming for 353 adjudicated primary outcome events.
  
  
  RESULTS
  The primary efficacy outcome is time to first recurrent stroke (ischemic, hemorrhagic, or unspecified). Key secondary outcomes are time to first ischemic stroke and time to first occurrence in the composite outcome of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death. The primary safety outcome is major hemorrhage, including symptomatic intracranial hemorrhage.
  
  
  CONCLUSIONS
  Acetylsalicylic acid is the most common antithrombotic given to patients with embolic strokes of undetermined source to reduce recurrence risk. This trial will determine whether anticoagulation with dabigatran is more effective than acetylsalicylic acid, and acceptably safe.
authors.affiliation: Department of Neurology and Stroke Center, University Hospital Essen, Essen, Germany.
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.affiliation: Department of Neurology, University of California-San Francisco, San Francisco, CA, USA.
authors.forename: J Donald
authors.initials: JD
authors.lastname: Easton
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.affiliation: Cardiovascular Therapeutic Area, Boehringer Ingelheim Ltd, Burlington, ON, Canada.
authors.forename: Lisa
authors.initials: L
authors.lastname: Cronin
authors.affiliation: Clinical Operations/Biometics and Data Management Department, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Duffy
authors.affiliation: Clinical Operations/Biometics and Data Management Department, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Cotton
authors.affiliation: Clinical Development and Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.|Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.affiliation: Department of Neurology, Miller School of Medicine, University of Miami, Miami, FL, USA.
authors.forename: Ralph L
authors.initials: RL
authors.lastname: Sacco
mesh_terms: D000284:Administration, Oral; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D020766:Intracranial Embolism / Q000188:drug therapy*; D011446:Prospective Studies; D012107:Research Design; D055502:Secondary Prevention; D020521:Stroke / Q000188:drug therapy*
chemical_list: D000991:Antithrombins; D005343:Fibrinolytic Agents; D000069604:Dabigatran; D001241:Aspirin
keywords: acetylsalicylic acid (ASA); clinical trial; dabigatran; minor stroke; stroke prevention; transient ischemic attack (TIA)