Pemafibrate for Symptomatic ICAS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized trial compares pemafibrate plus standard stroke care to standard care alone in adults with symptomatic intracranial atherosclerotic stenosis and elevated triglycerides. Participants will be followed for 12 months to see if treatment reduces progression of ICAS, improves triglyceride and vascular risk markers, and affects vascular events and functional outcomes. The study will monitor safety as well as effectiveness in preventing further vascular events after ischemic stroke or high-risk TIA. Eligible patients have 50-99% intracranial stenosis on CTA, fasting TG 150-499 mg/dL (or non-fasting 175-499 mg/dL), and are 18 years or older. The trial is sponsored by Tokyo Women's Medical University with collaborators and multiple sites in Japan.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujita Health University Hospital
  Toyoake, Aichi-ken, Japan Recruiting
• Tokyo Women's Medical University Yachiyo Medical Center
  Yachiyo, Chiba, Japan Recruiting
• Brain Attack Center Ota Memorial Hospital
  Fukuyama, Hiroshima, Japan Recruiting
• Hiroshima City Hiroshima Citizens Hospital
  Hiroshima, Hiroshima, Japan Recruiting
• Kobe City Medical Center General Hospital
  Kobe, Hyōgo, Japan Recruiting
• University of Tsukuba Hospital
  Tsukuba, Ibaraki, Japan Recruiting

Study contacts

• Study coordinator: Kenichi Todo, MD, PhD
• Email: todo.kenichi@twmu.ac.jp
• Phone: +81-3-3353-8111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Stroke care during COVID-19 waves: patterns in admissions and treatments

  This study tests how stroke and TIA care patterns changed during the later waves of the COVID-19 pandemic by analyzing hospital data on admissions, stays, thrombolysis, and thrombectomy.

  Recruiting at 4 sites Johannes Gutenberg University Mainz · Prague and 3 other locations · NCT07795021

• Photon-counting CT to check intracranial stents

  This study tests whether ultra-high-resolution photon-counting CT can reliably visualize intracranial stents and detect in-stent restenosis during follow-up of patients with prior stents.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07769814

• Health for Hungary: Long-term blood and health data collection to study aging and disease onset

  This study tests whether routine blood tests plus advanced molecular analyses can help detect the early stages of non-communicable diseases in adults over 40.

  Recruiting at 21 sites Center for Molecular Fingerprinting Research Nonprofit LLC · Balatonfüred and 32 other locations · NCT07743021

• Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

  This study tests a partly self-guided therapy program to help adults recover the use of their weaker arm after stroke, aiming to require less time with a therapist.

  Recruiting Ohio State University · Columbus, Ohio · NCT07723300

• Using IMPROVE to guide carotid revascularisation decisions

  This trial tests whether using the IMPROVE MRI-based score to select patients for carotid revascularisation is as good as standard care based mainly on stenosis degree, among people who have had a recent stroke or TIA due to carotid disease.

  Recruiting Maastricht University Medical Center · Arnhem, Gelderland and 9 other locations · NCT07556887

• NORAHOME: Home-based multimodal monitoring and care for people with minor stroke and TIA

  This project tests whether giving adults with minor stroke or TIA a multimodal home-hospitalization program can be as safe, reduce complications, and be more efficient than standard hospital care.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona · NCT07500116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.