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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
Languages: English
Types: Article
Subjects: clopidogrel, recurrence, bleeding, dipyridamole, acute ischemic stroke, aspirin, Protocols, acute TIA, statistical analysis plan, randomized controlled trial

Classified by OpenAIRE into

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.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

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    • 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.
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    • 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.
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    • 12 Zhao L, Gray LJ, Leonardi-Bee J, Weaver CS, Heptinstall S, Bath PM. Effect of aspirin, clopidogrel and dipyridamole on soluble markers of vascular function in nformal volunteers and patients with prior ischaemic stroke. Platelets 2006; 17:100-4.
    • 13 Sprigg N, Gray LJ, England T et al. A randomised controlled trial of triple antiplatelet therapy (Aspirin, Clopidogrel and Dipyridamole) in the secondary prevention of stroke: safety, tolerability and feasibility (ISRCTN 83673558). PLoS ONE 2008; 3:e2852.
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    • 17 Bath PMW, Geeganage CM, Gray LJ, Collier T, Pocock S. Use of ordinal outcomes in vascular prevention trials: comparison with binary outcomes in published stroke trials. Stroke 2008; 39:2817-23.
    • 18 Bath PM, Geeganage C, Gray LJ. Ordinal reanalysis of the SHEP trial. Stroke 2008; 39:e145.
    • 19 The Optimising Analysis of Stroke Trials (OAST) Collaboration. Can we improve the statistical analysis of stroke trials? Statistical re-analysis of functional outcomes in stroke trials. Stroke 2007; 38:1911-5.
    • 20 The Optimising Analysis of Stroke Trials (OAST) Collaboration. Calculation of sample size for stroke trials assessing functional outcome: comparison of binary and ordinal approaches. Int J Stroke 2008; 3:78- 84.
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    • 23 Bath PM, Lees KR, Schellinger PD et al. Statistical analysis of the primary outcome in acute stroke trials. Stroke 2012; 43:1171-8.
    • 24 (NICE) NIfHaCE. Clopidogrel and modifiedrelease dipyridamole in the prevention of occlusive vascular events National Institute for Health and Clincal Excellence, 2005.
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    • 27 Wardlaw J, Bath P, Sandercock P et al. The NeuroGrid stroke examplar clinical trial protocol. Int J Stroke 2007; 2:63-9.
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