Background: The risk of recurrence following an ischaemic stroke (IS) or transient ischaemic attack (TIA) is high, especially immediately after the event. Since one antiplatelet agent is more effective than none, and two are are superior to one, even more intensive treatment might be more effective in preventing recurrence.
Methods: TARDIS was an international prospective randomised open-label blinded-endpoint controlled trial. Patients with acute (<48 hours) non-cardioembolic IS or TIA were randomised to intensive antiplatelet therapy (combined aspirin, clopidogrel and dipyridamole) or guideline antiplatelets (clopidogrel alone, or combined aspirin and dipyridamole) given for one month. The primary outcome was stroke and TIA recurrence, and their severity (based on modified Rankin Scale), at 3 months. Patients or relatives gave written informed (proxy) consent and all sites had research ethics approval. The trial was funded by the British Heart Foundation and NIHR Health Technology Assessment programme.
Results: The Independent Data Monitoring Committee recommended stopping the trial in March 2016 since a definitive result had been reached. Of 3,096 patients, 2213 (71%) were enrolled with minor stroke (NIHSS <=3) or TIA. At baseline: mean age 69 (SD 10); male 62%; prior stroke 10%; diabetes 18%; index event IS 57%, TIA 43%; severity in IS (National Institutes of Health Stroke Scale) 1.8 (1.0); ABCD2 in TIA 5.1 (0.9); onset to randomisation <12 hours 11%, <24 hours 35%.
Summary: The results will be available for presentation in quarter 4 2016. TARDIS is large enough to influence clinical practice.