Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial

Not Applicable

Recruiting

• Conditions: Lacunar Stroke; Stroke; Ischemic Stroke
• Interventions: Drug: rt-PA; Drug: DAPT

• Registration Number: NCT07111559
• Lead Sponsor: Nippon Medical School

Brief Summary

The goal of this clinical trial is to learn if a combination of antiplatelet drugs works better than intravenous tissue plasminogen activator to treat small ischemic stroke (lacunar stroke). The main questions it aims to answer are:

Is a combination of antiplatelet drugs non-inferior to the current standard tissue plasminogen activator treatment? Does a combination of antiplatelet drugs reduce the bleeding complications than tissue plasminogen activator?

Researchers will compare a combination of antiplatelet drugs to tissue plasminogen activator to see if a combination of antiplatelet drugs works to treat small ischemic stroke (lacunar stroke).

Participants will:

Take a combination of antiplatelet drugs or be given intravenous tissue plasminogen activator Check the neurological status 3 months after stroke, in-person, by phone, or by mail.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-01
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Study First Posted: 2025-08-08
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-01
• Primary Completion: 2028-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age ≥ 18 years.
• Acute ischemic stroke within 4.5 hours from onset. If onset time is unknown because of impaired consciousness or aphasia, use the "last known well" time.
• A single perforating-artery infarct on brain MRI:

located in the corona radiata, putamen, internal capsule, thalamus, or pons; solitary, mainly round or oval, with a maximum diameter ≤ 20 mm; lesions only in the centrum semiovale are not allowed, but extension from the above sites into the centrum semiovale is allowed.

• No disability in daily life before the stroke (modified Rankin Scale ≤ 1).
• National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
• Written informed consent obtained.

Exclusion Criteria

• Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions.
• Any contraindication to intravenous rt-PA, without blood pressures.
• ≥ 50 % stenosis or occlusion of the artery responsible for the stroke * (see note below).
• Diseases that require anticoagulation (e.g., atrial fibrillation, deep-vein thrombosis) *
• Inability to take medicine orally.
• Any other reason judged by the principal investigator or co-investigators to make participation inappropriate.

Note: This study targets hyper-acute stroke within 4.5 hours. To avoid treatment delay, items marked with * must be judged using the similar examinations that each site normally performs before rt-PA administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rt-PA	rt-PA	-
DAPT	DAPT	-

Primary Outcome Measures

Name	Time	Method
Excellent outcome	3 months after stroke	Modified Rankin scale score of 0-1

Secondary Outcome Measures

Name	Time	Method
Infarct growth between Day 7 and admission	At Day 7	Infarct growth between Day 7 and admission on diffusion-weighted imaging
Early neurological deterioration	At Day 7	Increment in NIHSS score by 2 points or more from admission
NIHSS score on Day 7	At Day 7	NIHSS score on Day 7
Good outcome	At 3 months	mRS 0-2 at 3 months from stroke onset
mRS distribution at 3 months	At 3 months	mRS distribution (assessed by shift analysis) at 3 months from onset
Ischemic stroke recurrence	At 3 months	Ischemic stroke recurrence during 3 months from onset
Cost effectiveness of DAPT	Various (such as at 7 days or 3 months)	Cost effectiveness analysis comparing DAPT to rt-PA

Trial Locations

Locations (13)

Fukuoka Red Cross Hospital; 🇯🇵 Fukuoka, Japan

Shioda Hospital; 🇯🇵 Katsuura, Japan

Kohnan Hospital; 🇯🇵 Sendai, Japan

Tokushima University Hospital; 🇯🇵 Tokushima, Japan

Ota Memorial Hospital; 🇯🇵 Fukuyama, Japan

Kagoshima City Hospital; 🇯🇵 Kagoshima, Japan

Kagoshima Medical Center; 🇯🇵 Kagoshima, Japan

Nippon Medical School Tamanagayama hospital; 🇯🇵 Tama, Japan

Dokkyo Medical University Hospital; 🇯🇵 Tochigi, Japan

Juntendo University Hospital; 🇯🇵 Tokyo, Japan

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