Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Pemafibrate for Symptomatic ICAS RCT (PPAR-ICAS)

30 juli 2026 uppdaterad av: 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

270

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Pemafibrate group
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Läkemedel: Pemafibrate
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Inget ingripande: Non-pemafibrate group
Participants in this arm will receive standard medical therapy without pemafibrate.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tokyo Women's Medical University

Samarbetspartners

Kowa Company, Ltd.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 maj 2026

Primärt slutförande (Beräknad)

31 mars 2028

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

20 april 2026

Först inskickad som uppfyllde QC-kriterierna

25 april 2026

Första postat (Faktisk)

1 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • JIHS-C-005243-00

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera