title: Safety and efficacy of intensive vs. guideline antiplatelet therapy in high-risk patients with recent ischemic stroke or transient ischemic attack: rationale and design of the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial (ISRCTN47823388).
abstract: BACKGROUND
  The risk of recurrence following a stroke or transient ischemic attack is high, especially immediately after the event.
  
  
  OBJECTIVE
  Because two antiplatelet agents are superior to one in patients with non-cardioembolic events, more intensive treatment might be even more effective.
  The sample size of 4100 patients will allow a shift to less recurrence, and less severe recurrence, to be detected (odds ratio 0·68) with 90% power at 5% significance.
  
  
  METHODS
  Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (ISRCTN47823388) is comparing the safety and efficacy of intensive (combined aspirin, clopidogrel, and dipyridamole) vs. guideline antiplatelet therapy, both given for one-month. This international collaborative parallel-group prospective randomized open-label blinded-end-point phase III trial plans to recruit 4100 patients with acute ischemic stroke or transient ischemic attack. Randomization and data collection are performed over a secure Internet site with real-time data validation and concealment of allocation. Outcomes, serious adverse events, and neuroimaging are adjudicated centrally with blinding to treatment allocation.
  
  
  RESULTS
  The primary outcome is stroke recurrence and its severity ('ordinal recurrence' based on modified Rankin Scale) at 90 days, with masked assessment centrally by telephone. Secondary outcomes include vascular events, functional measures (disability, mood, cognition, quality of life), and safety (bleeding, death, serious adverse events).
  
  
  CONCLUSIONS
  The trial has recruited more than 50% of its target sample size (latest number: 2399) and is running in 104 sites in 4 countries. One-third of patients presented with a transient ischemic attack.
authors.forename: Kailash
authors.initials: K
authors.lastname: Krishnan
authors.forename: Maia
authors.initials: M
authors.lastname: Beridze
authors.forename: Hanne
authors.initials: H
authors.lastname: Christensen
authors.forename: Rob
authors.initials: R
authors.lastname: Dineen
authors.forename: Lelia
authors.initials: L
authors.lastname: Duley
authors.forename: Stan
authors.initials: S
authors.lastname: Heptinstall
authors.forename: Marilyn
authors.initials: M
authors.lastname: James
authors.forename: Hugh S
authors.initials: HS
authors.lastname: Markus
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.forename: Annemarei
authors.initials: A
authors.lastname: Ranta
authors.forename: Thompson
authors.initials: T
authors.lastname: Robinson
authors.forename: Nikola
authors.initials: N
authors.lastname: Nikola
authors.forename: Graham
authors.initials: G
authors.lastname: Venables
authors.forename: Philip
authors.initials: P
authors.lastname: Bath
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000367:Age Factors; D004562:Electrocardiography; D005500:Follow-Up Studies; D007391:International Cooperation; D002546:Ischemic Attack, Transient / Q000188:drug therapy; D008279:Magnetic Resonance Imaging; D017063:Outcome Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000592:standards / Q000627:therapeutic use; D012107:Research Design / Q000592:standards; D020521:Stroke / Q000188:drug therapy; D014057:Tomography, X-Ray Computed
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: acute stroke; aspirin; clopidogrel; dipyridamole; randomized controlled trial; transient ischemic attack