title: Acute Stroke or Transient Ischemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes (SOCRATES) trial: rationale and design.
abstract: BACKGROUND
  The risk of recurrent ischemia is high in the acute period after ischemic stroke and transient ischemic attack. Aspirin is recommended by guidelines for this indication, but more intensive antiplatelet therapy may be justified.
  
  
  OBJECTIVE
  We aim to evaluate whether ticagrelor, a potent antiplatelet agent that blocks the P2Y12 receptor without requiring metabolic activation, reduces the risk of major vascular events compared with aspirin when randomization occurs within 24 h after symptom onset of a nonsevere ischemic stroke or high-risk transient ischemic attack.
  
  
  METHODS
  Acute Stroke or Transient Ischemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes (SOCRATES) is a randomized, double-blind, event-driven trial and will include an estimated 13,600 participants randomized in 33 countries worldwide to collect 844 primary events.
  
  
  RESULTS
  The primary endpoint is the composite of stroke (ischemic or hemorrhagic), myocardial infarction, and death. Time to the first primary endpoint will be compared in the treatment groups during 90-day follow-up, with major hemorrhage serving as the primary safety endpoint. Participants will be followed for an additional 30 days after the randomized treatment period.
  
  
  CONCLUSIONS
  The SOCRATES trial fulfills an important clinical need by evaluating a potent antiplatelet agent as a superior alternative to current standard of care in patients presenting acutely with ischemic stroke or transient ischemic attack.
authors: Dean's Office, Dell Medical School, University of Texas, Austin, TX, USA.
authors: S Claiborne
authors: SC
authors: Johnston
authors: Department of Neurology and Stroke Center, Bichat University Hospital and Medical School, Paris, France.
authors: Pierre
authors: P
authors: Amarenco
authors: Stanford University Medical Center, Stanford Stroke Center, Palo Alto, CA, USA.
authors: Gregory W
authors: GW
authors: Albers
authors: AstraZeneca, Mölndal, Sweden.
authors: Hans
authors: H
authors: Denison
authors: Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
authors: J Donald
authors: JD
authors: Easton
authors: AstraZeneca, Mölndal, Sweden.
authors: Peter
authors: P
authors: Held
authors: AstraZeneca, Mölndal, Sweden.
authors: Jenny
authors: J
authors: Jonasson
authors: National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
authors: Kazuo
authors: K
authors: Minematsu
authors: Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.
authors: Carlos A
authors: CA
authors: Molina
authors: Department of Medicine & Therapeutics, Chinese University of Hong Kong, HKSAR, China.
authors: Lawrence K S
authors: LK
authors: Wong
mesh_terms: D000241:Adenosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use*; D004311:Double-Blind Method; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D002546:Ischemic Attack, Transient / Q000188:drug therapy* / Q000401:mortality; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use*; D012107:Research Design; D000077486:Ticagrelor; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D058921:Purinergic P2Y Receptor Antagonists; D000077486:Ticagrelor; D000241:Adenosine; D001241:Aspirin
keywords: acute stroke therapy; antiplatelet therapy; aspirin; ischaemic stroke; ticagrelor