TARDIS.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Individuals with acute non‐cardioembolic ischaemic stroke (less than 48 hours of onset) or acute TIA (less than 48 hours of onset) with 1 or more of: crescendo TIA (greater than 1 TIA within 1 week), and/or admitted on dual antiplatelet therapy (aspirin/dipyridamole, aspirin/clopidogrel, clopidogrel/dipyridamole), and/or with an ABCD2 score > 5 | |
| Interventions | Aspirin, clopidogrel, and dipyridamole vs aspirin and dipyridamole or clopidogrel | |
| Outcomes | Primary outcome: ordinal stroke severity at 90 days Secondary outcomes: binary and ordinal outcomes of stroke, TIA, MI, acute coronary syndrome, composite vascular outcome, death. Also safety (ordinal bleeding events), tolerability, and feasibility. Additional measures included transcranial Doppler for embolic events, laboratory measures (FBC and P‐Selectin), clinical efficacy (NIHSS), function (mRS, BI), cognition (TICS), quality of life (EuroQoL, EQ‐5D), mood (Zung), disposition, days at home, and economic activity | |
| Notes | Estimated study completion date: March 2017 (5 years duration from start‐up phase) 3096 participants recruited from the UK and internationally, to assess the efficacy, safety, and health economics of triple therapy, with endpoints measured at 7, 35, and 90 days. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐based 1:1 ratio simple randomisation, with stratification and minimisation |
| Allocation concealment (selection bias) | Low risk | Methods described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Outcome blinded assessment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes validated and categorised by expert adjudicators masked to treatment assignment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All accounted for as lost to follow‐up or refused. |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
BI: Barthel Index
CT: computed tomography
DWI: diffusion weighted imaging
FBC: full blood count
ICH: intracerebral haemorrhage
MI: myocardial infarction
MRA: magnetic resonance angiography
MRI: magnetic resonance imaging
mRS: modified Rankin Scale
NIHSS: National Institutes of Health Stroke Scale
RCT: randomised controlled trial
TIA: transient ischaemic attack
TICS: Telephone Interview for Cognitive Status