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Pemafibrate for Symptomatic ICAS RCT

RecruitingNAAges 18 Years - anyAllTokyo Women's Medical University
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In plain words

What the trial is, and whether it could suit you

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. P

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Pemafibrate
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Where

37 sites
Fujita Health University Hospital
Toyoake, Japan
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo, Japan
Brain Attack Center Ota Memorial Hospital
Fukuyama, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
University of Tsukuba Hospital
Tsukuba, Japan
Iwate Medical University Hospital
Hizume, Japan
Kagoshima Medical Center
Kagoshima, Japan

โ€ฆand 29 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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