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Pemafibrate for Symptomatic ICAS RCT (PPAR-ICAS)

2026年7月30日 更新者：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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

270

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Pemafibrate group
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
药品：Pemafibrate
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
无干预：Non-pemafibrate group
Participants in this arm will receive standard medical therapy without pemafibrate.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])
大体时间：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

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tokyo Women's Medical University

合作者

Kowa Company, Ltd.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月26日

初级完成 (估计的)

2028年3月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年4月20日

首先提交符合 QC 标准的

2026年4月25日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • JIHS-C-005243-00

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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