title: Statistical analysis plan for the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial.
abstract: BACKGROUND
  Antiplatelet agents such as aspirin, clopidogrel and dipyridamole are effective in reducing the risk of recurrence after a stroke. Importantly, the risk of recurrence is highest immediately after the index event while antiplatelets cause bleeding.
  
  
  OBJECTIVE
  The 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial is testing whether short-term intensive antiplatelet therapy is safe and effective in reducing the early risk of recurrence as compared with standard guideline-based therapy.
  
  
  METHODS
  TARDIS is an international multi-center prospective randomized open-label blinded-end-point trial, with funding from the UK Health Technology Assessment program. Patients with acute ischemic stroke or transient ischemic attack are randomized within 48 h to intensive/triple antiplatelet therapy or guideline antiplatelets taken for one-month. Patients or relatives give written informed (proxy) consent and all sites have research ethics approval. Analyses will be done by intention-to-treat.
  
  
  RESULTS
  The primary outcome is shift in stroke recurrent events and their severity, assessed using the modified Rankin Scale, at three-months.
  
  
  CONCLUSIONS
  This paper and attachment describe the trial's statistical analysis plan, as developed from the protocol during recruitment and prior to unblinding of data. The statistical analysis plan contains design and methods for analyses, and unpopulated tables and figures for the primary and baseline publications. The data from the trial will provide the first large-scale randomized evidence for the use of intensive antiplatelet therapy for preventing recurrence after acute stroke and transient ischemic attack.
authors: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
authors: Philip M W
authors: PM
authors: Bath
authors: Katie
authors: K
authors: Robson
authors: Lisa J
authors: LJ
authors: Woodhouse
authors: Nikola
authors: N
authors: Sprigg
authors: Robert
authors: R
authors: Dineen
authors: Stuart
authors: S
authors: Pocock
mesh_terms: D001241:Aspirin / Q000627:therapeutic use; D002545:Brain Ischemia / Q000150:complications; D000077144:Clopidogrel; D004176:Dipyridamole / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D017063:Outcome Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D010975:Platelet Aggregation Inhibitors; D004176:Dipyridamole; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: acute TIA; acute ischemic stroke; aspirin; bleeding; clopidogrel; dipyridamole; randomized controlled trial; recurrence; statistical analysis plan
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