Statistical analysis plan for the ‘Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke’ (TARDIS) trial

Article English OPEN
Bath, Philip M W ; Robson, Katie ; Woodhouse, Lisa J ; Sprigg, Nikola ; Dineen, Robert ; Pocock, Stuart (2014)
  • Publisher: BlackWell Publishing Ltd
  • Journal: International Journal of Stroke (issn: 1747-4930, vol: 10, pp: 449-451)
  • Related identifiers: doi: 10.1111/ijs.12445, doi: 10.1111/ijs.12445/abstract, pmc: PMC4409839
  • Subject: clopidogrel | recurrence | bleeding | dipyridamole | acute ischemic stroke | aspirin | Protocols | acute TIA | statistical analysis plan | randomized controlled trial
    mesheuropmc: cardiovascular diseases

Rationale: 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.\ud Aims and/or hypothesis: 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.\ud Design: 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.\ud Study Outcome: The primary outcome is shift in stroke recurrent events and their severity, assessed using the modified Rankin Scale, at three-months.\ud Discussion: 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.
  • References (27)
    27 references, page 1 of 3

    1 Rothwell PM, Giles MF, Chandratheva A et al. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol 2007; 370:1432-42.

    2 Lavallee PC, Meseguer E, Abboud H et al. A transient ischaemic attach clinic with round-the-clock access (SOS0TIA): feasibility and effects. Lancet Neurol 2007; 6:953-60.

    3 International Stroke Trial Collaborative Group. The International Stroke Trial (IST); a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. Lancet 1997; 349:1569-81.

    4 CAST (Chinese Acute Stroke Trial) Collaborative Group. CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. Lancet 1997; 349:1641-9.

    5 Geeganage CM, Diener H-C, Algra A et al. Dual or mono antiplatelet therapy for patients with acute ischemic stroke or transient ischemic attack stroke, 2012. 43.

    6 Wang Y, Wang Y, Zhao X et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med 2013; 369:11-9.

    7 Wong KSL, Wang Y, Leng X et al. Early dual versus mono antiplatelet therapy for acute non-cardioembolic ischemic stroke or transient ischemic attack: an updated systematic review and meta-analysis. Circulation 2013; 128:1656-66.

    8 Zhao L, Bath P, Heptinstall S. Effects of combining three different antiplatelet agents on platelets and leukocytes in whole blood in vitro. Br J Pharmacol 2001; 134:353-8.

    9 Scholz T, Zhao L, Temmler U, Bath P, Heptinstall S, Losche W. The GPIIb/IIIa antagonist eptifibatide markedly potentiates plateletleukocyte interaction and tissue factor expression following platelet activation in whole blood in vitro. Platelets 2002; 13:401-6.

    10 Zhao L, Bath PMW, Fox S et al. The effects of GPII-IIIa antagonists and a combination of three other antiplatelet agents on plateletleukocyte interactions. Curr Med Res Opin 2003; 19:178-86.

  • Related Research Results (1)
  • Metrics
    No metrics available
Share - Bookmark