Early DAPT (aspirin plus ticagrelor) added to intravenous thrombolysis improved excellent functional outcomes at 90 days versus placebo (68.7% vs 62.0%; RR 1.11, 95% CI 1.03-1.20; p=0.0089).
RCT (n=1,382)
Double-blind
1:1
Yes
Does early oral dual antiplatelet therapy (aspirin plus ticagrelor) improve excellent functional outcomes at 90 days when added to intravenous thrombolysis in patients with acute ischaemic stroke?
Early initiation of aspirin and ticagrelor within 6 hours of intravenous thrombolysis for moderate ischemic stroke significantly improves 90-day functional outcomes without a statistically significant increase in symptomatic intracranial hemorrhage.
Effect estimate: RR 1.11 (95% CI 1.03-1.20)
Absolute Event Rate: 68.7% vs 62%
p-value: p=0.0089
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.
“Early DAPT significantly improved the rate of excellent functional outcome at 90 days (68.7% vs 62.0%; RR 1.11; p=0.0089) without a meaningful increase in symptomatic intracranial haemorrhage, representing an important advance in acute stroke care pending validation in broader populations.”
Wang et al. (Fri,) conducted a rct in Ischaemic stroke (n=1,382). Oral aspirin plus ticagrelor (early DAPT) vs. Placebo was evaluated on Excellent functional outcome (modified Rankin Scale score 0-1) at 90 days (RR 1.11, 95% CI 1.03-1.20, p=0.0089). Early DAPT (aspirin plus ticagrelor) added to intravenous thrombolysis improved excellent functional outcomes at 90 days versus placebo (68.7% vs 62.0%; RR 1.11, 95% CI 1.03-1.20; p=0.0089).