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 international trial of intensive/triple antiplatelet therapy in acute IS and TIA, and included participants representative of patients in many western stroke services.
Funders: National Institute of Health Research Health Technology Assessment Programme and British Heart Foundation. Trial registration: ISRCTN47823388