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NCT Number: NCT07111559

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Yamanashi Hospital, Chūō, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rt-PA

Drug

Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.

DAPT

Drug

Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.

Primary outcomes

  1. Excellent outcome

    Time frame: 3 months after stroke

    Modified Rankin scale score of 0-1

Secondary outcomes

  1. Infarct growth between Day 7 and admission

    Time frame: At Day 7

    Infarct growth between Day 7 and admission on diffusion-weighted imaging

  2. Early neurological deterioration

    Time frame: At Day 7

    Increment in NIHSS score by 2 points or more from admission

  3. NIHSS score on Day 7

    Time frame: At Day 7

    NIHSS score on Day 7

  4. Good outcome

    Time frame: At 3 months

    mRS 0-2 at 3 months from stroke onset

  5. mRS distribution at 3 months

    Time frame: At 3 months

    mRS distribution (assessed by shift analysis) at 3 months from onset

  6. Ischemic stroke recurrence

    Time frame: At 3 months

    Ischemic stroke recurrence during 3 months from onset

  7. Cost effectiveness of DAPT

    Time frame: Various (such as at 7 days or 3 months)

    Cost effectiveness analysis comparing DAPT to rt-PA

Other outcomes

  1. Safety - symptomatic intracerebral hemorrhage

    Time frame: At 24 hours from the initial treatment

    symptomatic intracerebral hemorrhage

  2. Safety - any intracranial bleeding

    Time frame: At 14 days from admission

    any intracranial bleeding

  3. Safety - other hemorrhagic complications

    Time frame: At 14 days from admission

    other hemorrhagic complications

  4. Safety - all-cause mortality

    Time frame: At 3 months

    all-cause mortality

  5. Safety - cerebrovascular death

    Time frame: At 3 months

    cerebrovascular death

Study contacts

Contact information is provided by the study sponsor or research team.

Yuki Sakamoto

CONTACT

[email protected]

+81-3-3822-2131 ext. 24508

Sponsors and collaborators

Lead sponsor

Nippon Medical School

Other

Collaborators

  • Japan Research Foundation for Clinical Pharmacology
  • Takeda Science Foundation - Medical Research Grant

Registry information

Official study title

A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction

Acronym: LACUNAR-tPA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 8, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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