Intracranial Atherosclerotic Disease study: Pemafibrate
Official title Pemafibrate for Symptomatic ICAS RCT
ClinicalTrials.gov ID: NCT07562178
What this study is testing
What is Pemafibrate?
Pemafibrate is an investigational oral medicine being studied as a potential treatment to prevent worsening of intracranial atherosclerotic disease. Pemafibrate is designed to activate the PPARα receptor, which helps lower triglyceride levels and may improve vascular health.
Also referred to as K-877.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if pemafibrate can reduce worsening of brain artery narrowing and improve blood fat levels over 12 months, while also checking safety and overall stroke outcomes.
- Who it's for
- Adults 18 + who had a recent stroke or TIA, have 50‑99% narrowing in a brain artery, and have high triglyceride levels.
- What's involved
- Participants are randomly placed into a pemafibrate group or a usual‑care group; the pemafibrate group takes the drug for a year with dose adjustments, and everyone has regular blood tests, brain scans, and other vascular checks.
- Time commitment
- The trial lasts 12 months with visits for blood work and imaging at the start, during the year, and at the end.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \>=4) between 24 hours and 3 years from onset at enrollment.
- Contrast-enhanced CT angiography (CTA) within 3 months prior to consent demonstrating 50-99% stenosis (WASID criteria) in a symptomatic intracranial...
- Fasting triglycerides (TG) 150-499 mg/dL, or non-fasting TG 175-499 mg/dL, measured within 4 weeks prior to consent.
- Men or women aged \>=18 years at the time of consent.
- Ability to obtain written informed consent from the patient or a legally authorized representative.
You likely can't join if
- Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial...
- Patients with \>=70% stenosis of the extracranial carotid artery (NASCET criteria).
- Patients with neurological deterioration within 24 hours prior to enrollment.
- Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment.
- Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or...
- Patients who meet any contraindication to pemafibrate, including: (1) History of hypersensitivity to pemafibrate
The study team makes the final eligibility decision.
Where it is enrolling
- Toyoake, Aichi-ken, Japan
- Yachiyo, Chiba, Japan
- Fukuyama, Hiroshima, Japan
- Hiroshima, Hiroshima, Japan
- Kobe, Hyōgo, Japan
- Tsukuba, Ibaraki, Japan
- Hizume, Iwate, Japan
- Kagoshima, Kagoshima-ken, Japan
- Isehara, Kanagawa, Japan
- Kawasaki, Kanagawa, Japan
- Kumamoto, Kumamoto, Japan
- Kyoto, Kyoto, Japan
- Nagasaki, Nagasaki, Japan
- Kurashiki, Okayama-ken, Japan
- Hirakata, Osaka, Japan
- Osaka, Osaka, Japan
- Sakai, Osaka, Japan
- Suita, Osaka, Japan
- Hidaka, Saitama, Japan
- Saitama, Saitama, Japan
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toyoake, Aichi-ken, Japan; Yachiyo, Chiba, Japan; Fukuyama, Hiroshima, Japan; Hiroshima, Hiroshima, Japan; Kobe, Hyōgo, Japan; Tsukuba, Ibaraki, Japan and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.