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Can a Cholesterol-Lowering drug stop brain arteries from narrowing further?

NCT ID NCT07562178

Disease control Sponsor: Tokyo Women's Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests whether pemafibrate, a drug that lowers triglycerides, can prevent the worsening of narrowed brain arteries in people who have already had a stroke or mini-stroke. About 270 participants will be randomly assigned to receive either pemafibrate plus standard care or standard care alone for 12 months. The main goal is to see if the drug reduces further artery narrowing, which could lower the risk of another stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pemafibrate
What this could lead to
If it works, this could offer a new way to lower the risk of recurrent stroke or TIA in patients with high triglycerides and narrowed brain arteries.
What could go wrong
This is a relatively small, open-label trial (Phase not specified), so results may not be definitive. The drug may not prevent artery progression or could cause side effects like liver or kidney issues.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 270 people

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

Started

May 2026

Expected to finish

Dec 2028

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: 1. Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \>=4) between 24 hours and 3 years from onset at enrollment. 2. Contrast-enhanced CT angiography (CTA) within 3 months prior to consent demonstrating 50-99% stenosis (WASID criteria) in a symptomatic intracranial artery: intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1), vertebral artery (V4), basilar artery, or posterior cerebral artery (P1). 3. Fasting triglycerides (TG) 150-499 mg/dL, or non-fasting TG 175-499 mg/dL, measured within 4 weeks prior to consent. 4. Men or women aged \>=18 years at the time of consent. 5. Ability to obtain written informed consent from the patient or a legally authorized representative. Exclusion Criteria: 1. Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial dissection). 2. Patients with \>=70% stenosis of the extracranial carotid artery (NASCET criteria). 3. Patients with neurological deterioration within 24 hours prior to enrollment. 4. Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment. 5. Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or cerebral bypass surgery). 6. Patients who meet any contraindication to pemafibrate, including: (1) History of hypersensitivity to pemafibrate; (2) Severe hepatic impairment or liver cirrhosis classified as Child-Pugh B or C; (3) Cholelithiasis; (4) Pregnancy or suspected pregnancy; (5) Concomitant use of cyclosporine or rifampin. 7. Patients who have taken pemafibrate or any fibrate within 12 weeks prior to consent. 8\. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia. 11\. Patients with severe systemic comorbidities with an expected survival \<12 months. 12\. Patients who may be pregnant, are pregnant, or are breastfeeding. 13. Any other condition for which the principal or sub-investigator judges participation to be inappropriate.

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Conditions

The condition(s) this trial relates to.

cerebral artery stenosis cerebral atherosclerosis hypertriglyceridemia intracranial arterial disease intracranial arteriosclerosis ischemic stroke stroke disorder transient ischemic attack

As listed by the trial registrant

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

Hypertriglyceridaemia Intracranial atherosclerotic disease (ICAD) Stroke (CVA) or tia

How to take part

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

  1. The places running it

    37 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

  • Brain Attack Center Ota Memorial Hospital

    NOT_YET_RECRUITING

    Fukuyama, Hiroshima, 720-0825, Japan

  • Dokkyo Medical University Hospital

    RECRUITING

    Mibu, Tochigi, 321-0293, Japan

  • Fujita Health University Hospital

    NOT_YET_RECRUITING

    Toyoake, Aichi-ken, 470-1192, Japan

  • Hiroshima City Hiroshima Citizens Hospital

    NOT_YET_RECRUITING

    Hiroshima, Hiroshima, 730-8518, Japan

  • Institute of Science Tokyo Hospital

    NOT_YET_RECRUITING

    Bunkyō-Ku, Tokyo, 113-8519, Japan

  • Iwate Medical University Hospital

    RECRUITING

    Hizume, Iwate, 028-3695, Japan

  • Japanese Red Cross Kyoto Daini Hospital

    RECRUITING

    Kyoto, Kyoto, 602-8026, Japan

  • Japanese Red Cross Saitama Hospital

    RECRUITING

    Saitama, Saitama, 330-8553, Japan

  • Jichi Medical University Hospital

    RECRUITING

    Shimotsuke, Tochigi, 329-0498, Japan

  • Kagoshima Medical Center

    RECRUITING

    Kagoshima, Kagoshima-ken, 892-0853, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Kawasaki Medical School Hospital

    RECRUITING

    Kurashiki, Okayama-ken, 701-0192, Japan

  • Kindai University Hopital

    NOT_YET_RECRUITING

    Sakai, Osaka, 590-0197, Japan

  • Kobe City Medical Center General Hospital

    NOT_YET_RECRUITING

    Kobe, Hyōgo, 650-0047, Japan

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, Kumamoto, 860-8556, Japan

  • Kyorin University Hospital

    RECRUITING

    Mitaka, Tokyo, 181-8611, Japan

  • Nagasaki University Hospital

    RECRUITING

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nippon Medical School Hospital

    NOT_YET_RECRUITING

    Bunkyō-Ku, Tokyo, 113-8603, Japan

  • Nippon Medical School Musashikosugi Hospital

    NOT_YET_RECRUITING

    Kawasaki, Kanagawa, 211-8533, Japan

  • Nippon Medical School Tamanagayama Hospital

    NOT_YET_RECRUITING

    Tama, Tokyo, 206-8512, Japan

  • Osaka General Medical Center

    RECRUITING

    Osaka, Osaka, 558-8558, Japan

  • Osaka Keisatsu Hospital

    RECRUITING

    Osaka, Osaka, 543-0042, Japan

  • Osaka National Hospital

    RECRUITING

    Osaka, Osaka, 540-0006, Japan

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Saitama, 350-1298, Japan

  • Showa General Hospital

    RECRUITING

    Kodaira, Tokyo, 187-8510, Japan

  • The Jikei University Hspital

    NOT_YET_RECRUITING

    Minato-Ku, Tokyo, 105-8471, Japan

  • The University of Osaka Hospital

    NOT_YET_RECRUITING

    Suita, Osaka, 565-0871, Japan

  • Tokai University Hopital

    NOT_YET_RECRUITING

    Isehara, Kanagawa, 259-1193, Japan

  • Tokushima University Hospital

    NOT_YET_RECRUITING

    Tokushima, Tokushima, 770-8503, Japan

  • Tokyo Medical University Hospital

    RECRUITING

    Shinjuku-Ku, Tokyo, 160-0023, Japan

  • Tokyo Saiseikai Central Hospital

    NOT_YET_RECRUITING

    Minato-Ku, Tokyo, 108-0073, Japan

  • Tokyo Women's Medical University Adachi Medical Center

    NOT_YET_RECRUITING

    Adachi-ku, Tokyo, 123-8558, Japan

  • Tokyo Women's Medical University Hospital

    RECRUITING

    Shinjuku-Ku, Tokyo, 162-8666, Japan

  • Tokyo Women's Medical University Yachiyo Medical Center

    NOT_YET_RECRUITING

    Yachiyo, Chiba, 276-8524, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, Kyoto, 602-8566, Japan

  • University of Tsukuba Hospital

    NOT_YET_RECRUITING

    Tsukuba, Ibaraki, 305-8576, Japan

  • University of Yamanashi Hospital

    RECRUITING

    Chūō, Yamanashi, 409-3898, Japan

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