Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial

Bath, Philip M.W. and Appleton, Jason P. and Beridze, M. and Christensen, Hanne and Dineen, Robert A. and Duley, Lelia and England, Timothy J. and Heptinstall, Stan and James, Marilyn and Krishnan, Kailash and Markus, H.S. and Pocock, Stuart J. and Ranta, A. and Robinson, Thompson G. and Flaherty, Katie and Scutt, Polly and Venables, G. and Woodhouse, Lisa J. and Sprigg, Nikola (2016) Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial. International Journal of Stroke . ISSN 1747-4949

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Abstract

Background: The risk of recurrence following ischaemic stroke (IS) or transient ischaemic attack (TIA) is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus.

Design: The Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial was an international multicentre prospective randomised open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute IS or TIA. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life) and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD).

Results: Recruitment ran from April 2009 to March 2016. 3,096 patients were recruited from 106 sites in 4 countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomisation characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomisation 29.4 (11.9) hours; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), TIA 953 (30.8%).

Conclusion: TARDIS was a large trial of intensive/triple antiplatelet therapy in acute IS and TIA, and included participants from four predominantly Caucasian countries who were representative of patients in many western stroke services.

Item Type: Article
Keywords: Acute ischaemic stroke, Acute transient ischaemic attack (TIA), Aspirin, Bleeding, Clopidogrel, Dipyridamole, Randomised controlled trial
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Rehabilitation and Ageing
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Identification Number: https://doi.org/10.1177/1747493016677988
Depositing User: Eprints, Support
Date Deposited: 21 Nov 2016 11:41
Last Modified: 24 Feb 2017 21:08
URI: http://eprints.nottingham.ac.uk/id/eprint/38851

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