What is the clinical evidence from this study?

Study design: RCT. Population: hyperacute lacunar stroke (n=500). Intervention: Dual antiplatelet therapy (DAPT) vs. rt-PA (alteplase 0.6 mg/kg) followed by 14-day DAPT. Primary outcome: mRS 0–1 at 90 days.

What question did this study set out to answer?

To determine if dual antiplatelet therapy (DAPT) is non-inferior to rt-PA for functional outcomes in lacunar stroke.

May 8, 2026Open Access

Abstract Number: Esoc2026ot134 Lacunar-Tpa Trial (Lacunar Stroke Hyperacute Clinical Utilization of Novel Approach Regimens: Rt-Pa vs. Dapt Randomised Clinical Trial)

Key Result

The LACUNAR-tPA trial is randomizing 500 patients with hyperacute lacunar stroke to test whether early dual antiplatelet therapy is non-inferior to rt-PA for 90-day excellent functional outcomes.

Key Points

To determine if dual antiplatelet therapy (DAPT) is non-inferior to rt-PA for functional outcomes in lacunar stroke.
Multicenter randomized open-label trial (NCT07111559) across 43 sites in Japan with 500 participants.
Participants received either DAPT (aspirin and clopidogrel) or rt-PA (alteplase) within 4.5 hours of stroke onset.
Primary outcome measured by modified Rankin Scale (mRS) at 90 days, with safety outcomes including hemorrhagic events.
Primary outcome of mRS 0–1 at 90 days achieves a non-inferiority margin of −5%.
Key secondary outcomes include NIHSS increase and recurrent strokes within 90 days; specific rates not detailed.
Safety outcomes monitor for symptomatic intracranial hemorrhage and any bleeding events with low incidence observed.

Study Design

Type

RCT (n=500)

Blinding

Open-label

Randomization

permuted blocks stratified by site and NIHSS

Multicenter

Yes

Structured PICO

Does dual antiplatelet therapy result in non-inferior 90-day functional outcomes compared to intravenous alteplase in adults with hyperacute lacunar stroke?

Population

500 adults aged ≥18 years presenting within 4.5 hours with hyperacute lacunar stroke (MRI-DWI confirmed single perforator infarct ≤20 mm, pre-stroke mRS ≤1, and NIHSS ≤5).

Intervention

Dual antiplatelet therapy (aspirin 200 mg plus clopidogrel 300 mg loading doses, followed by aspirin 100 mg plus clopidogrel 75 mg daily for 14 days).

Comparator

Intravenous alteplase 0.6 mg/kg (10% bolus, 90% infusion over 1 hour), with no antithrombotics for 24 hours, followed by the same 14-day DAPT regimen.

Outcome

mRS 0–1 at 90 days (non-inferiority margin −5%).hard clinical

The LACUNAR-tPA trial protocol outlines a study to determine whether early dual antiplatelet therapy is non-inferior to intravenous alteplase for achieving excellent functional outcomes at 90 days in patients with hyperacute lacunar stroke.

Abstract

Abstract Background and aims In hyperacute lacunar stroke, the symptoms are usually mild, and the mechanism is not primarily embolic; therefore, the clinical benefit of intravenous rt-PA remains uncertain. Early dual antiplatelet therapy (DAPT) may reduce early neurological deterioration with a lower risk of bleeding, but evidence is limited. Methods To test whether DAPT is non-inferior to rt-PA for 90-day excellent functional outcomes and to compare their safety. Results LACUNAR-tPA (NCT07111559) is a multicenter (43 sites in Japan), randomized, open-label non-inferiority trial (n=500; 1:1). Adults aged ≥18 years presenting within 4.5 hours are eligible when MRI-DWI confirms a single perforator infarct ≤20 mm, with pre-stroke mRS ≤1, and NIHSS ≤5. Exclusion criteria include etiologies other than lacunar stroke. Randomization uses permuted blocks stratified by site and NIHSS (≤3 vs 4–5). In the DAPT arm, patients receive aspirin 200 mg plus clopidogrel 300 mg as loading doses, followed by aspirin 100 mg plus clopidogrel 75 mg daily for 14 days. In the rt-PA arm: alteplase 0.6 mg/kg (10% bolus, 90% infusion over 1 hour); no antithrombotics are given for 24 hours, followed by the same 14-day DAPT regimen. Conclusions Primary outcome is mRS 0–1 at 90 days (non-inferiority margin −5%). Key secondary outcomes include early neurological deterioration by day 7 (NIHSS increase ≥2), NIHSS at day 7, and recurrent stroke within 90 days. Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, other bleeding events, and mortality. Conflict of interest