IV rt-PA versus two-antiplatelet drug combo (DAPT) for small (lacunar) ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, interventional Phase 4 trial compares dual antiplatelet therapy (DAPT) with standard intravenous tissue‑plasminogen activator (rt‑PA) in adults who have a single small perforating‑artery (lacunar) infarct confirmed on MRI within 4.5 hours of symptom onset. Eligible patients have mild deficits (NIHSS ≤ 5) and minimal pre‑stroke disability (mRS ≤ 1) and are randomized to receive either DAPT or IV rt‑PA. Investigators will monitor for functional recovery and bleeding complications and will check neurological status at 3 months in person, by phone, or by mail. The study is designed to see if DAPT is non‑inferior to rt‑PA for functional outcome and whether it lowers bleeding risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Yamanashi Hospital
  Chūō, Japan Recruiting
• University of Fukui Hospital
  Fukui, Japan Recruiting
• Fukuoka Red Cross Hospital
  Fukuoka, Japan Recruiting
• Ota Memorial Hospital
  Fukuyama, Japan Recruiting
• Kansai Medical University Hospital
  Hirakata, Japan Recruiting
• Kagoshima City Hospital
  Kagoshima, Japan Recruiting

Study contacts

• Principal investigator: Yuki Sakamoto — Nippon Medical School
• Study coordinator: Yuki Sakamoto
• Email: yuki-sakamoto@nms.ac.jp
• Phone: +81-3-3822-2131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.