RecruitingNot ApplicableNCT07562178

Pemafibrate for Symptomatic ICAS RCT

Triglyceride-lowering Therapy With Pemafibrate for Prevention of Atherosclerotic Cardiovascular Disease in Patients With Symptomatic Intracranial Artery Stenosis: a Multi-center, Open-label, Randomized Controlled Trial (PPAR-ICAS)


Sponsor

Tokyo Women's Medical University

Enrollment

270 participants

Start Date

May 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA). The main questions this study aims to answer are: 1. Does pemafibrate lower the chance that ICAS gets worse over 12 months? 2. Does pemafibrate improve TG levels and other vascular risk markers? 3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months? Researchers will compare a pemafibrate group with a non-pemafibrate group to see whether pemafibrate helps prevent progression of ICAS. This is an open-label, randomized, parallel-group trial. That means participants are assigned by chance to 1 of 2 groups, and both the researchers and participants know which group was assigned. Participants in both groups will continue to receive standard stroke care, including antithrombotic therapy and management of vascular risk factors such as blood pressure, low-density lipoprotein cholesterol, diabetes, and smoking. Participants may be eligible if they are 18 years or older, have clinically stable ischemic stroke or TIA, have 50% to 99% stenosis in a symptomatic intracranial artery on contrast-enhanced CT angiography (CTA), and have elevated fasting (\>=150 mg/dL) or non-fasting (\>=175 mg/dL) TG levels. Some people will not be eligible, such as those with ICAS due to non-atherosclerotic arterial disease, severe extracranial carotid stenosis, recent intravenous thrombolysis or mechanical thrombectomy, planned revascularization, contraindications to pemafibrate or iodinated contrast media, dialysis, or pregnancy. Participants will: * Be randomly assigned to a pemafibrate group or a non-pemafibrate group * Take pemafibrate for 12 months if assigned to the pemafibrate group, with possible dose adjustment based on TG levels and kidney function * Have blood tests and clinical assessments at baseline and during follow-up * Undergo brain CTA at study entry and again at 12 months * Undergo brain MRI/MRA and vascular tests such as ankle brachial index, cardio ankle vascular index, and pulse wave velocity according to the study schedule * Be followed for vascular events, functional outcome, and adverse events for 1 year


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pemafibrate for people with hypertriglyceridaemia, intracranial atherosclerotic disease (icad), and other related conditions. The study is currently recruiting participants at 19 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPemafibrate

Participants in this arm will receive pemafibrate in addition to standard medical therapy.


Locations(37)

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Tokyo Women's Medical University Yachiyo Medical Center

Yachiyo, Chiba, Japan

Brain Attack Center Ota Memorial Hospital

Fukuyama, Hiroshima, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Hiroshima, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Iwate Medical University Hospital

Hizume, Iwate, Japan

Kagoshima Medical Center

Kagoshima, Kagoshima-ken, Japan

Tokai University Hopital

Isehara, Kanagawa, Japan

Nippon Medical School Musashikosugi Hospital

Kawasaki, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Kyoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Kawasaki Medical School Hospital

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Osaka National Hospital

Osaka, Osaka, Japan

Osaka Keisatsu Hospital

Osaka, Osaka, Japan

Osaka General Medical Center

Osaka, Osaka, Japan

Kindai University Hopital

Sakai, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Japanese Red Cross Saitama Hospital

Saitama, Saitama, Japan

Dokkyo Medical University Hospital

Mibu, Tochigi, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Tokushima University Hospital

Tokushima, Tokushima, Japan

Tokyo Women's Medical University Adachi Medical Center

Adachi-ku, Tokyo, Japan

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

Nippon Medical School Hospital

Bunkyō-Ku, Tokyo, Japan

Showa General Hospital

Kodaira, Tokyo, Japan

The Jikei University Hspital

Minato-Ku, Tokyo, Japan

Tokyo Saiseikai Central Hospital

Minato-Ku, Tokyo, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Nippon Medical School Tamanagayama Hospital

Tama, Tokyo, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

View Full Details on ClinicalTrials.gov

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NCT07562178


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