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Pemafibrate for Symptomatic ICAS RCT (PPAR-ICAS)

30 juli 2026 bijgewerkt door: Kenichi Todo, Tokyo Women's Medical University

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)

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

270

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Japan
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Nog niet aan het werven
        • Fujita Health University Hospital
        • Contact:
    • Chiba
      • Yachiyo, Chiba, Japan, 276-8524
        • Nog niet aan het werven
        • Tokyo Women's Medical University Yachiyo Medical Center
        • Contact:
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0825
        • Nog niet aan het werven
        • Brain Attack Center Ota Memorial Hospital
        • Contact:
      • Hiroshima, Hiroshima, Japan, 730-8518
        • Nog niet aan het werven
        • Hiroshima City Hiroshima Citizens Hospital
        • Contact:
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Nog niet aan het werven
        • Kobe City Medical Center General Hospital
        • Contact:
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Nog niet aan het werven
        • University of Tsukuba Hospital
        • Contact:
    • Iwate
      • Hizume, Iwate, Japan, 028-3695
        • Werving
        • Iwate Medical University Hospital
        • Contact:
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 892-0853
        • Werving
        • Kagoshima Medical Center
        • Contact:
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Nog niet aan het werven
        • Tokai University Hopital
        • Contact:
      • Kawasaki, Kanagawa, Japan, 211-8533
        • Nog niet aan het werven
        • Nippon Medical School Musashikosugi Hospital
        • Contact:
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Werving
        • University Hospital Kyoto Prefectural University of Medicine
        • Contact:
      • Kyoto, Kyoto, Japan, 602-8026
        • Werving
        • Japanese Red Cross Kyoto Daini Hospital
        • Contact:
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Werving
        • Nagasaki University Hospital
        • Contact:
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 701-0192
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Werving
        • Kansai Medical University Hospital
        • Contact:
      • Osaka, Osaka, Japan, 558-8558
      • Osaka, Osaka, Japan, 543-0042
      • Osaka, Osaka, Japan, 540-0006
        • Werving
        • Osaka National Hospital
        • Contact:
      • Sakai, Osaka, Japan, 590-0197
      • Suita, Osaka, Japan, 565-0871
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Werving
        • Saitama Medical University International Medical Center
        • Contact:
      • Saitama, Saitama, Japan, 330-8553
        • Werving
        • Japanese Red Cross Saitama Hospital
        • Contact:
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Werving
        • Dokkyo Medical University Hospital
        • Contact:
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Werving
        • Jichi Medical University Hospital
        • Contact:
    • Tokushima
      • Tokushima, Tokushima, Japan, 770-8503
        • Nog niet aan het werven
        • Tokushima University Hospital
        • Contact:
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 123-8558
        • Nog niet aan het werven
        • Tokyo Women's Medical University Adachi Medical Center
        • Contact:
      • Bunkyō-Ku, Tokyo, Japan, 113-8519
        • Nog niet aan het werven
        • Institute of Science Tokyo Hospital
        • Contact:
      • Bunkyō-Ku, Tokyo, Japan, 113-8603
        • Nog niet aan het werven
        • Nippon Medical School Hospital
        • Contact:
      • Kodaira, Tokyo, Japan, 187-8510
      • Minato-Ku, Tokyo, Japan, 108-0073
        • Nog niet aan het werven
        • Tokyo Saiseikai Central Hospital
        • Contact:
      • Minato-Ku, Tokyo, Japan, 105-8471
        • Nog niet aan het werven
        • The Jikei University Hspital
        • Contact:
      • Mitaka, Tokyo, Japan, 181-8611
        • Werving
        • Kyorin University Hospital
        • Contact:
      • Shinjuku-Ku, Tokyo, Japan, 162-8666
        • Werving
        • Tokyo Women's Medical University Hospital
        • Contact:
      • Shinjuku-Ku, Tokyo, Japan, 160-0023
        • Werving
        • Tokyo Medical University Hospital
        • Contact:
      • Tama, Tokyo, Japan, 206-8512
        • Nog niet aan het werven
        • Nippon Medical School Tamanagayama hospital
        • Contact:
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Werving
        • University of Yamanashi Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pemafibrate group
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Geneesmiddel: Pemafibrate
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Geen tussenkomst: Non-pemafibrate group
Participants in this arm will receive standard medical therapy without pemafibrate.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])
Tijdsspanne: Baseline and 12 months

Stenosis is assessed by the WASID method; progression is defined as an absolute increase of >=10 percentage points in percent stenosis or the development of occlusion, stability as a change of <10 percentage points in either direction, and improvement as an absolute decrease of >=10 percentage points.

If, during follow-up, emergency or unplanned revascularization (mechanical thrombectomy, percutaneous transluminal angioplasty, stent placement, or bypass surgery) is performed for the target culprit vessel lesion evaluated at registration in relation to progression or occlusion of that lesion, the case will be classified as "progression" regardless of the availability of CTA findings at 12 months.
Baseline and 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Key secondary endpoint (supplementary analyses of the primary endpoint): Change in intracranial arterial stenosis on CTA at 12 months from enrollment (three categories: progression, no change, improvement)
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Key secondary endpoint (supplementary analyses of the primary endpoint): Improvement in intracranial arterial stenosis on CTA at 12 months from enrollment (improvement vs. no improvement [progression or no change])
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Change in percent stenosis by the WASID method
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Proportion of intracranial arterial stenosis progression/improvement per the TOSS and TOSS-2 criteria
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Proportion of intracranial arterial stenosis progression/improvement per the Wong KS criteria
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
All-cause mortality
Tijdsspanne: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Change in Fazekas scale on brain MRI
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Change in number of cerebral microbleeds on brain MRI
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Change in total cerebral small vessel disease score on brain MRI
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Changes in blood biomarkers
Tijdsspanne: Baseline, 3 months, 6 months, and 12 months
Complete blood count; fasting TG, HDL-C, LDL-C, RLP-C; apolipoprotein C-III; lipoprotein(a); fasting plasma glucose; HbA1c; AST, ALT, gamma-GTP; creatinine, eGFR; CK; CRP, high-sensitivity CRP; IL-6; total homocysteine; PT-INR; APTT; fibrinogen; D-dimer
Baseline, 3 months, 6 months, and 12 months
Safety: occurrence of adverse events and illnesses
Tijdsspanne: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Activities of daily living by mRS score (mRS 0-1, 0-2, and 0-3 proportions, and the overall mRS score distribution)
Tijdsspanne: Baseline and 12 months
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability or death; therefore, higher scores indicate a worse outcome.
Baseline and 12 months
Changes in ankle-brachial index (ABI)
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Change in cardio-ankle vascular index (CAVI)
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Change in pulse wave velocity (PWV)
Tijdsspanne: Baseline and 12 months
Baseline and 12 months
Major cardiovascular events (MACE)
Tijdsspanne: From enrollment to the end of treatment at 12 months

The following individual events and their composite:

Ischemic stroke (fatal, nonfatal), TIA, intracranial hemorrhage (fatal, nonfatal), any stroke (ischemic stroke, TIA, intracranial hemorrhage), emergency or unplanned revascularization procedures, including mechanical thrombectomy, percutaneous transluminal angioplasty, stent placement, or bypass surgery Myocardial infarction (fatal, nonfatal), any coronary artery disease event (myocardial infarction, or angina treated with PCI or CABG) Symptomatic peripheral artery disease (with intermittent claudication, ulceration, or gangrene; or requiring revascularization) Vascular death
From enrollment to the end of treatment at 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tokyo Women's Medical University

Medewerkers

Kowa Company, Ltd.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

26 mei 2026

Primaire voltooiing (Geschat)

31 maart 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

20 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • JIHS-C-005243-00

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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