BACKGROUND: Evidence supporting the early addition of antiplatelet therapy to intravenous thrombolysis in patients with acute ischaemic stroke remains inconclusive. We aimed to investigate the efficacy and safety of early oral dual antiplatelet therapy (DAPT), started within 6 h of onset, as an adjunct to intravenous thrombolysis.
METHODS: TAPIS was a randomised, double-blind, placebo-controlled trial done in 60 hospitals across China. We enrolled patients treated with intravenous thrombolysis for ischaemic stroke, with a National Institutes of Health Stroke Scale score of 4-10. We randomly assigned (1:1) patients to receive oral aspirin plus ticagrelor (DAPT group) or corresponding placebo within 6 h of stroke onset, either before, during, or after receiving thrombolysis. Ticagrelor or placebo was continued for days 2-7 in each group, with open-label aspirin administered for days 2-90. Patients, clinicians, and investigators were masked to the group assignment. The primary efficacy outcome was an excellent functional outcome (modified Rankin Scale score 0-1) at 90 days. The primary safety outcome was symptomatic intracranial haemorrhage within 36 h. This trial was registered with ClinicalTrials.gov (NCT06316570) and is completed.
FINDINGS: Between April 3, 2024, and Sept 30, 2025, we randomly assigned 1382 patients to the early DAPT (n=690 [49·9%]) or placebo (n=692 [50·1%]) groups. The median age was 65·6 years (IQR 58·3-72·0), 991 (71·7%) were men, and 391 (28·3%) were women. At 90 days, 474 (68·7%) patients in the early DAPT group and 429 (62·0%) in the placebo group achieved excellent functional outcomes (risk ratio 1·11 [95% CI 1·03-1·20; p=0·0089). Symptomatic intracranial haemorrhage within 36 h occurred in six (0·9%) patients in the early DAPT group versus five (0·7%) in the control group (risk ratio 1·20 [95% CI 0·37-3·93; p=0.76).
INTERPRETATION: Among patients treated with intravenous thrombolysis for moderate ischaemic stroke, initiation of oral DAPT within 6 h of onset improved the likelihood of excellent functional outcomes at 90 days. Although no significant between-group difference in symptomatic intracranial haemorrhage was detected, wide CIs precluded exclusion of a small increased risk.
FUNDING: National Natural Science Foundation of China, Capital's Funds for Health Improvement and Research, Noncommunicable Chronic Diseases-National Science and Technology Major Project, Beijing Municipal Science & Technology Commission, and the New Cornerstone Science Foundation.
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This study demonstrated a modest improvement in excellent functional outcomes and a very low risk (in either group) of intracranial hemorrhage. Overall, this study is beginning to give clarity to an area of remaining ambiguity in current AHA ischemic stroke practice guidelines. Although, not necessarily practice-changing in isolation, I expect future guidelines will incorporate the data from this trial along with the results of other similar studies being run in parallel.
This placebo-controlled double blind RCT shows the benefit and safety of ticagrelor and aspirin dual antiplatelet therapy early after starting standard intravenous thrombolysis in acute ischemic stroke. But this is for moderate stroke severity (up to NIH Stroke scale of 10). This is a novel finding (counters a prior small study), but its small but detectable benefit and relative safety of this approach might change practice.
Very important study but it was done exclusively in China. The distribution of stroke mechanisms was predominantly large-artery atherosclerosis and small artery occlusion. We know that DAPT is effective, especially in atherosclerotic disease. Furthermore, the rate of protocol violation in this study was approximately 10%, which might introduce potential bias. For these reasons, further confirmatory clinical trials across diverse settings are warranted to validate the generalisability of the findings.
Limited external generalisability as 0.7% with cardiotonic stroke, whereas this accounts for the bulk in local stroke population. Important information but not a big game-changer.
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