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New treatment option for Intracranial Atherosclerotic Disease (ICAD)
Official title Pemafibrate for Symptomatic ICAS RCT
ClinicalTrials.gov ID: NCT07562178
What this study is testing
What is Pemafibrate?
Pemafibrate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intracranial atherosclerotic disease (icad).
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 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.
- 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; (2) Severe hepatic impairment or...
The study team makes the final eligibility decision.
Where it's taking place
- Hizume, Iwate, Japan
- Kagoshima, Kagoshima-ken, Japan
- Kumamoto, Kumamoto, Japan
- Kyoto, Kyoto, Japan
- Nagasaki, Nagasaki, Japan
- Kurashiki, Okayama-ken, Japan
- Hirakata, Osaka, Japan
- Osaka, Osaka, Japan
- Hidaka, Saitama, Japan
- Saitama, Saitama, Japan
- Mibu, Tochigi, Japan
- Shimotsuke, Tochigi, Japan
- Kodaira, Tokyo, Japan
- Mitaka, Tokyo, Japan
- Shinjuku-Ku, Tokyo, Japan
- Chūō, Yamanashi, Japan
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 - 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?
Study sites include Hizume, Iwate, Japan; Kagoshima, Kagoshima-ken, Japan; Kumamoto, Kumamoto, Japan; Kyoto, Kyoto, Japan; Nagasaki, Nagasaki, Japan; Kurashiki, Okayama-ken, Japan and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.