title: Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design.
abstract: BACKGROUND
  Ischemic stroke and other vascular outcomes occur in 10-20% of patients in the three-months following a transient ischemic attack or minor ischemic stroke, and many are disabling. The highest risk period for these outcomes is the early hours and days immediately following the ischemic event. Aspirin is the most common antithrombotic treatment used for these patients.
  
  
  OBJECTIVE
  The aim of POINT is to determine whether clopidogrel plus aspirin taken <12 h after transient ischemic attack or minor ischemic stroke symptom onset is more effective in preventing major ischemic vascular events at 90 days in the high-risk, and acceptably safe, compared with aspirin alone.
  
  
  METHODS
  POINT is a prospective, randomized, double-blind, multicenter trial in patients with transient ischemic attack or minor ischemic stroke. Subjects are randomized to clopidogrel (600 mg loading dose followed by 75 mg/day) or matching placebo, and all will receive open-label aspirin 50-325 mg/day, with a dose of 162 mg daily for five-days followed by 81 mg daily strongly recommended.
  
  
  RESULTS
  The primary efficacy outcome is the composite of new ischemic vascular events - ischemic stroke, myocardial infarction, or ischemic vascular death - by 90 days. The primary safety outcome is major hemorrhage, which includes symptomatic intracranial hemorrhage.
  
  
  CONCLUSIONS
  Aspirin is the most common antithrombotic given to patients with a stroke or transient ischemic attack, as it reduces the risk of subsequent stroke. This trial expects to determine whether more aggressive antithrombotic therapy with clopidogrel plus aspirin, initiated acutely, is more effective than aspirin alone.
authors.affiliation: Department of Neurology, University of California, San Francisco, CA, USA. clay.johnston@ucsfmedctr.org
authors.forename: S Claiborne
authors.initials: SC
authors.lastname: Johnston
authors.forename: J Donald
authors.initials: JD
authors.lastname: Easton
authors.forename: Mary
authors.initials: M
authors.lastname: Farrant
authors.forename: William
authors.initials: W
authors.lastname: Barsan
authors.forename: Holly
authors.initials: H
authors.lastname: Battenhouse
authors.forename: Robin
authors.initials: R
authors.lastname: Conwit
authors.forename: Catherine
authors.initials: C
authors.lastname: Dillon
authors.forename: Jordan
authors.initials: J
authors.lastname: Elm
authors.forename: Anne
authors.initials: A
authors.lastname: Lindblad
authors.forename: Lewis
authors.initials: L
authors.lastname: Morgenstern
authors.forename: Sharon N
authors.initials: SN
authors.lastname: Poisson
authors.forename: Yuko
authors.initials: Y
authors.lastname: Palesch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage*; D001792:Blood Platelets / Q000187:drug effects / Q000378:metabolism; D000077144:Clopidogrel; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D002546:Ischemic Attack, Transient / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D012107:Research Design; D020521:Stroke / Q000188:drug therapy* / Q000517:prevention & control*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: TIA; aspirin; clinical trial; clopidogrel; minor stroke; stroke prevention