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Pemafibrate for Symptomatic ICAS RCT (PPAR-ICAS)

13. maj 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

270

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Japan
    • Iwate
      • Hizume, Iwate, Japan, 028-3695
        • Ikke rekrutterer endnu
        • Iwate Medical University Hospital
        • Kontakt:
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 892-0853
        • Ikke rekrutterer endnu
        • Kagoshima Medical Center
        • Kontakt:
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Ikke rekrutterer endnu
        • Kumamoto University Hospital
        • Kontakt:
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Rekruttering
        • University Hospital Kyoto Prefectural University of Medicine
        • Kontakt:
      • Kyoto, Kyoto, Japan, 602-8026
        • Ikke rekrutterer endnu
        • Japanese Red Cross Kyoto Daini Hospital
        • Kontakt:
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Ikke rekrutterer endnu
        • Nagasaki University Hospital
        • Kontakt:
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 701-0192
        • Ikke rekrutterer endnu
        • Kawasaki Medical School Hospital
        • Kontakt:
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Ikke rekrutterer endnu
        • Kansai Medical University Hospital
        • Kontakt:
      • Osaka, Osaka, Japan, 540-0006
        • Ikke rekrutterer endnu
        • Osaka National Hospital
        • Kontakt:
      • Osaka, Osaka, Japan, 558-8558
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Ikke rekrutterer endnu
        • Saitama Medical University International Medical Center
        • Kontakt:
      • Saitama, Saitama, Japan, 330-8553
        • Ikke rekrutterer endnu
        • Japanese Red Cross Saitama Hospital
        • Kontakt:
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Rekruttering
        • Dokkyo Medical University Hospital
        • Kontakt:
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Rekruttering
        • Jichi Medical University Hospital
        • Kontakt:
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-8510
        • Rekruttering
        • Showa General Hospital
        • Kontakt:
      • Mitaka, Tokyo, Japan, 181-8611
        • Ikke rekrutterer endnu
        • Kyorin University Hospital
        • Kontakt:
      • Shinjuku-Ku, Tokyo, Japan, 162-8666
        • Rekruttering
        • Tokyo Women's Medical University Hospital
        • Kontakt:
      • Shinjuku-Ku, Tokyo, Japan, 160-0023
        • Ikke rekrutterer endnu
        • Tokyo Medical University Hospital
        • Kontakt:
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Ikke rekrutterer endnu
        • University of Yamanashi Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pemafibrate group
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Medicin: Pemafibrate
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Ingen indgriben: Non-pemafibrate group
Participants in this arm will receive standard medical therapy without pemafibrate.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])
Tidsramme: 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.
Baseline and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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])
Tidsramme: Baseline and 12 months
Baseline and 12 months
Change in percent stenosis by the WASID method
Tidsramme: Baseline and 12 months
Baseline and 12 months
Proportion of intracranial arterial stenosis progression/improvement per the TOSS and TOSS-2 criteria
Tidsramme: Baseline and 12 months
Baseline and 12 months
Proportion of intracranial arterial stenosis progression/improvement per the Wong KS criteria
Tidsramme: Baseline and 12 months
Baseline and 12 months
Major cardiovascular events (MACE)
Tidsramme: 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) 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
All-cause mortality
Tidsramme: 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
Tidsramme: Baseline and 12 months
Baseline and 12 months
Change in number of cerebral microbleeds on brain MRI
Tidsramme: Baseline and 12 months
Baseline and 12 months
Change in total cerebral small vessel disease score on brain MRI
Tidsramme: Baseline and 12 months
Baseline and 12 months
Changes in blood biomarkers
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline and 12 months
Baseline and 12 months
Change in cardio-ankle vascular index (CAVI)
Tidsramme: Baseline and 12 months
Baseline and 12 months
Change in pulse wave velocity (PWV)
Tidsramme: Baseline and 12 months
Baseline and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tokyo Women's Medical University

Samarbejdspartnere

Kowa Company, Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. marts 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

25. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JIHS-C-005243-00

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Slagtilfælde (CVA) eller TIA

Kliniske forsøg med Pemafibrate

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