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Pemafibrate for Symptomatic ICAS RCT (PPAR-ICAS)

2026년 7월 30일 업데이트: 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

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

270

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Pemafibrate group
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
의약품: Pemafibrate
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
간섭 없음: Non-pemafibrate group
Participants in this arm will receive standard medical therapy without pemafibrate.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])
기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tokyo Women's Medical University

협력자

Kowa Company, Ltd.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 26일

기본 완료 (추정된)

2028년 3월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 20일

QC 기준을 충족하는 최초 제출

2026년 4월 25일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 30일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • JIHS-C-005243-00

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다