TAPIS
(2026)Objective
To investigate the efficacy and safety of early oral dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, started within 6 h of onset, as an adjunct to intravenous thrombolysis in patients with acute ischaemic stroke.
Study Summary
• Symptomatic intracranial haemorrhage within 36 h occurred in 0.9% (DAPT) vs 0.7% (placebo) (RR 1.20, 95% CI 0.37–3.93; p=0.76)
• Early ticagrelor + aspirin within 6 h of stroke onset improved functional outcomes without a statistically significant increase in sICH, though wide CIs could not exclude a small increased risk
Intervention
Loading dose of ticagrelor 180 mg + aspirin 100 mg on day 1, followed by ticagrelor 90 mg twice daily for days 2–7, plus open-label aspirin 100 mg daily for days 2–90, initiated within 6 h of stroke onset (before, during, or after IV thrombolysis).
Inclusion Criteria
Adults 18–80 years with acute ischaemic stroke, NIHSS 4–10 (with ≥1 point on a limb motor subitem), who received or intended to receive IV thrombolysis with alteplase (0.9 mg/kg) or tenecteplase (0.25 mg/kg) within 4.5 h of symptom onset; randomisation within 6 h of onset.
Study Design
Arms: Early DAPT: ticagrelor + aspirin (n=690) vs Placebo (n=692)
Patients per Arm: 690 vs 692
Outcome
• Symptomatic intracranial haemorrhage within 36 h: 0.9% DAPT vs 0.7% placebo (RR 1.20, 95% CI 0.37–3.93; p=0.76)
• No statistically significant increase in sICH, but wide CIs could not exclude a modest increase in risk
Bottom Line
In patients with moderate acute ischaemic stroke (NIHSS 4–10) treated with IV thrombolysis, initiation of oral dual antiplatelet therapy with ticagrelor plus aspirin within 6 h of onset improved the likelihood of excellent functional outcomes (mRS 0–1) at 90 days, with no statistically significant increase in symptomatic intracranial haemorrhage — though wide CIs could not exclude a small increased risk.
Major Points
- Early oral DAPT with ticagrelor + aspirin within 6 h of onset improved excellent functional outcomes (mRS 0–1) at 90 days: 68.7% vs 62.0% (RR 1.11, 95% CI 1.03–1.20; p=0.0089).
- Symptomatic intracranial haemorrhage within 36 h was infrequent and not significantly different: 0.9% vs 0.7% (RR 1.20, 95% CI 0.37–3.93; p=0.76).
- Wide CIs on the sICH outcome could not exclude a small increased risk.
- Trial enrolled 1382 patients across 60 sites in China with NIHSS 4–10 receiving alteplase or tenecteplase within 4.5 h.
- Provides high-quality evidence supporting early adjunctive oral DAPT in moderate stroke after thrombolysis, a population where prior evidence (EAST, TREND-IVT, ARTIS, MOST) was inconclusive or negative.
Study Design
- Study Type
- Multicentre, randomised, double-blind, parallel-group, placebo-controlled trial
- Randomization
- Yes
- Blinding
- Double-blind; patients, clinicians, and investigators masked; site-stratified blocked randomisation (block size 4) by independent statistician; identical placebo tablets
- Sample Size
- 1382
- Follow-up
- 90 days
- Centers
- 60
- Countries
- China
Primary Outcome
Definition: Excellent functional outcome defined as modified Rankin Scale score 0–1
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 429/692 (62.0%) | 474/690 (68.7%) | - (1.03–1.20) | 0.0089 |
Limitations & Criticisms
- Conducted exclusively in China — generalisability to other populations (e.g., non-Asian, different stroke epidemiology, different thrombolytic practice) may be limited.
- Excluded patients with planned endovascular therapy, limiting applicability to the large contemporary cohort eligible for mechanical thrombectomy.
- Restricted to moderate severity stroke (NIHSS 4–10); results may not extend to mild (<4) or severe (>10) strokes.
- Wide confidence intervals around the sICH risk ratio (0.37–3.93) cannot exclude a clinically meaningful small increased haemorrhage risk.
- Upper age limit of 80 years excludes the very elderly, a group at highest stroke risk.
- Open-label aspirin from day 2 onward in both arms means the trial primarily tests the early loading dose + ticagrelor strategy, not chronic DAPT.
Citation
Wang A, Xia X, Tang Y, et al. Ticagrelor with aspirin dual antiplatelet therapy combined with intravenous thrombolysis in patients with ischaemic stroke in China (TAPIS): a multicentre, double-blind, randomised controlled trial. Lancet. Published online May 8, 2026. doi:10.1016/S0140-6736(26)00757-9