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TAPIS

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

Year of Publication: 2026

Authors: Wang A, Xia X, Tang Y, ..., on behalf of the TAPIS Investigators

Journal: The Lancet

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

Link: https://doi.org/10.1016/S0140-6736(26)00757-9

Clinical Question

In patients with moderate acute ischaemic stroke receiving IV thrombolysis, does early oral ticagrelor plus aspirin within 6 h of onset improve functional outcomes without increasing symptomatic intracranial haemorrhage?

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.

      

Design

Study Type: Multicentre, randomised, double-blind, parallel-group, placebo-controlled trial

Randomization: 1

Blinding: Double-blind; patients, clinicians, and investigators masked; site-stratified blocked randomisation (block size 4) by independent statistician; identical placebo tablets

Allocation: 1:1

Enrollment Period: April 3, 2024 to September 30, 2025

Follow-up Duration: 90 days

Centers: 60

Countries: China

Sample Size: 1382

Analyzed: 1382

Analysis: Intention-to-treat; missing primary outcomes imputed by last observation carried forward (60-day, 30-day, or 7-day mRS)

Power Calculation: 1380 patients (690 per group) provided ~90% power to detect a 9% absolute difference in excellent functional outcomes at 90 days, assuming 60% in control and 10% dropout; final significance threshold set at 0.048

Registration: ClinicalTrials.gov NCT06316570

Inclusion Criteria

Age 18–80 years
Diagnosed with acute ischaemic stroke
NIHSS score 4–10 before intravenous thrombolysis, with at least 1 point on any NIHSS limb motor subitem
Received or intended to receive IV thrombolysis with alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) within 4.5 h of symptom onset
Randomisation completed within 6 h of stroke onset (last-seen-well time)

Exclusion Criteria

Planned endovascular therapy
Pre-existing disability with mRS score ≥2
Receipt of any antiplatelet therapy after symptom onset
Pre-existing atrial fibrillation
Use of anticoagulants

Baseline Characteristics

Characteristic	Overall	Early DAPT	Placebo
Total N	1382
Median Age (years)	65.6 (IQR 58.3–72.0)
Men	991 (71.7%)
Women	391 (28.3%)
N		690	692
Proportion		49.9%	50.1%

Arms

Field	Early DAPT (Ticagrelor + Aspirin)	Control
N	690	692
Intervention	Day 1: ticagrelor 180 mg loading (90 mg x 2) + aspirin 100 mg. Days 2–7: ticagrelor 90 mg twice daily. Days 2–90: open-label aspirin 100 mg daily. Initiated within 6 h of stroke onset (before, during, or after IV thrombolysis).	Day 1: two tablets ticagrelor placebo + one tablet aspirin placebo. Days 2–7: matching ticagrelor placebo. Days 2–90: open-label aspirin 100 mg daily.
Duration	Ticagrelor for 7 days; aspirin for 90 days	Placebo for 7 days; open-label aspirin for days 2–90

Outcomes

Outcome	Type	Control	Intervention	HR / OR / RR	P-value
Excellent functional outcome defined as modified Rankin Scale score 0–1	Primary	429/692 (62.0%)	474/690 (68.7%)	1.11	0.0089
Functional independence (mRS 0–2) at 90 days	Secondary	Not reported in available text
Ordinal distribution of mRS at 90 days (shift analysis)	Secondary	Not reported in available text
Neurological improvement at 7 days (NIHSS decrease ≥4 from baseline)	Secondary	Not reported in available text
Quality of life at 90 days (EQ-5D-5L and EQ-5D-VAS)	Secondary	Not reported in available text
Independence in activities of daily living at 90 days (Barthel Index 95–100)	Secondary	Not reported in available text
Recurrent ischaemic stroke within 90 days after randomisation	Secondary	Not reported in available text
Symptomatic intracranial haemorrhage within 36 h (ECASS III criteria)	Safety	5/692 (0.7%)	6/690 (0.9%)	1.2	0.76
Symptomatic intracranial haemorrhage within 7 days	Safety	Not reported in available text
Symptomatic intracranial haemorrhage with parenchymal haematoma type 2 within 36 h and 7 days (SITS-MOST criteria)	Safety	Not reported in available text
Any bleeding events within 90 days (GUSTO criteria)	Safety	Not reported in available text
All investigator-reported adverse events and serious adverse events within 90 days	Safety	Not reported in available text

Subgroup Analysis

Not reported in available text

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.

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; New Cornerstone Science Foundation

Based on: TAPIS (The Lancet, 2026)

Authors: Wang A, Xia X, Tang Y, ..., on behalf of the TAPIS Investigators

Content summarized and formatted by NeuroTrials.ai.

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

• Early DAPT achieved excellent functional outcome (mRS 0–1) at 90 days in 68.7% vs 62.0% with placebo (RR 1.11, 95% CI 1.03–1.20; p=0.0089)
• 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

• Excellent functional outcome (mRS 0–1) at 90 days: 68.7% DAPT vs 62.0% placebo (RR 1.11, 95% CI 1.03–1.20; p=0.0089)
• 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

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

View Original Publication →

TAPIS

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

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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