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New hope for stroke patients: could a pill combo replace the needle?

NCT ID NCT07111559

Disease control Sponsor: Nippon Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study compares two treatments for small ischemic strokes (lacunar strokes): a combination of antiplatelet drugs (pills) versus the standard clot-busting drug tPA given through an IV. The goal is to see if the pill combo works just as well but causes fewer bleeding problems. About 500 adults who have had a small stroke within the last 4.5 hours will take part, and their recovery will be checked after 3 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cerebral infarction ischemic stroke stroke disorder Stroke, Lacunar

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke Lacunar stroke Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dokkyo Medical University Hospital

    RECRUITING

    Tochigi, Japan

  • Fukuoka Red Cross Hospital

    RECRUITING

    Fukuoka, Japan

  • Japanese Red Cross Kyoto Daini Hospital

    RECRUITING

    Kyoto, Japan

  • Jichi Medical University Hospital

    RECRUITING

    Shimotsuke, Japan

  • Juntendo University Hospital

    RECRUITING

    Tokyo, Japan

  • Juntendo University Urayasu Hospital

    RECRUITING

    Urayasu, Japan

  • Kagoshima City Hospital

    RECRUITING

    Kagoshima, Japan

  • Kagoshima Medical Center

    RECRUITING

    Kagoshima, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Japan

  • Kawasaki Medical School General Medical Center

    RECRUITING

    Okayama, Japan

  • Kawasaki Medical School Hospital

    RECRUITING

    Kurashiki, Japan

  • Kohnan Hospital

    RECRUITING

    Sendai, Japan

  • National Cerebral and Cardiovascular Center

    RECRUITING

    Osaka, Japan

  • Nippon Medical School Tamanagayama hospital

    RECRUITING

    Tama, Japan

  • Nippon Medical School hospital

    RECRUITING

    Tokyo, Japan

  • Ota Memorial Hospital

    RECRUITING

    Fukuyama, Japan

  • Science Tokyo Hospital

    RECRUITING

    Tokyo, Japan

  • Shioda Hospital

    RECRUITING

    Katsuura, Japan

  • St. Marianna University School of Medicine Hospital

    RECRUITING

    Kawasaki, Japan

  • The Jikei University Hospital

    RECRUITING

    Minatoku, Japan

  • The Jikei University West Medical Center

    RECRUITING

    Komae, Japan

  • Tokushima University Hospital

    RECRUITING

    Tokushima, Japan

  • Tokyo Rosai Hospital

    RECRUITING

    Tokyo, Japan

  • Tokyo Saiseikai Central Hospital

    RECRUITING

    Tokyo, Japan

  • Tokyo Women's Medical University Hospital

    RECRUITING

    Tokyo, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, Japan

  • University of Fukui Hospital

    RECRUITING

    Fukui, Japan

  • University of Yamanashi Hospital

    RECRUITING

    Chūō, Japan

  • Yamaguchi University Hospital

    RECRUITING

    Ube, Japan

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