Open AccessSafety and efficacy of intensive vs. guideline antiplatelet therapy in high‐risk patients with recent ischemic stroke or transient ischemic attack: rationale and design of the T riple A ntiplatelets for R educing D ependency after I schaemic S troke ( TARDIS ) trial ( ISRCTN 47823388)
Author(s) -
Kailash Krishnan,
Maia Beridze,
Hanne Christensen,
Rob Dineen,
Lelia Duley,
Stan Heptinstall,
Marilyn James,
Hugh S Markus,
Stuart Pocock,
Annemarei Ranta,
Thompson Robinson,
Nikola Nikola,
Graham Venables,
Philip Bath
Publication year - 2015
Publication title -
international journal of stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.375
H-Index - 74
eISSN - 1747-4949
pISSN - 1747-4930
DOI - 10.1111/ijs.12538
Subject(s) - medicine , stroke (engine) , guideline , odds ratio , clopidogrel , randomized controlled trial , clinical endpoint , aspirin , cardiology , mechanical engineering , pathology , engineering
Rationale The risk of recurrence following a stroke or transient ischemic attack is high, especially immediately after the event. Hypothesis Because two antiplatelet agents are superior to one in patients with non‐cardioembolic events, more intensive treatment might be even more effective. Sample size estimates The sample size of 4100 patients will allow a shift to less recurrence, and less severe recurrence, to be detected (odds ratio 0·68) with 90% power at 5% significance. Methods and design T riple A ntiplatelets for R educing D ependency after I schaemic S troke ( ISRCTN 47823388) is comparing the safety and efficacy of intensive (combined aspirin, clopidogrel, and dipyridamole) vs. guideline antiplatelet therapy, both given for one‐month. This international collaborative parallel‐group prospective randomized open‐label blinded‐end‐point phase III trial plans to recruit 4100 patients with acute ischemic stroke or transient ischemic attack. Randomization and data collection are performed over a secure I nternet site with real‐time data validation and concealment of allocation. Outcomes, serious adverse events, and neuroimaging are adjudicated centrally with blinding to treatment allocation. Study outcome The primary outcome is stroke recurrence and its severity (‘ordinal recurrence’ based on modified R ankin S cale) at 90 days, with masked assessment centrally by telephone. Secondary outcomes include vascular events, functional measures (disability, mood, cognition, quality of life), and safety (bleeding, death, serious adverse events). Discussion The trial has recruited more than 50% of its target sample size (latest number: 2399) and is running in 104 sites in 4 countries. One‐third of patients presented with a transient ischemic attack.