An interventional study of Pemafibrate in Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia and Stroke (CVA) or TIA, sponsored by Tokyo Women's Medical University. Recruiting at 42 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Tokyo Women's Medical University · Not applicable, Interventional, and Treatment
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:
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:
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 270 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Tokyo Women's Medical University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(1) History of to pemafibrate; (2) Severe hepatic impairment or liver cirrhosis classified as 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Drug: Pemafibrate
Participants in this arm will receive standard medical therapy without pemafibrate.
Participants in this arm will receive pemafibrate in addition to standard medical therapy.
Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])
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.
Time frame: Baseline and 12 months
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)
Time frame: 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])
Time frame: Baseline and 12 months
Change in percent stenosis by the WASID method
Time frame: Baseline and 12 months
Proportion of intracranial arterial stenosis progression/improvement per the TOSS and TOSS-2 criteria
Time frame: Baseline and 12 months
Proportion of intracranial arterial stenosis progression/improvement per the Wong KS criteria
Time frame: Baseline and 12 months
Major cardiovascular events (MACE)
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
Time frame: From enrollment to the end of treatment at 12 months
All-cause mortality
Time frame: 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)
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.
Time frame: Baseline and 12 months
Change in Fazekas scale on brain MRI
Time frame: Baseline and 12 months
Change in number of cerebral microbleeds on brain MRI
Time frame: Baseline and 12 months
Change in total cerebral small vessel disease score on brain MRI
Time frame: Baseline and 12 months
Changes in ankle-brachial index (ABI)
Time frame: Baseline and 12 months
Change in cardio-ankle vascular index (CAVI)
Time frame: Baseline and 12 months
Change in pulse wave velocity (PWV)
Time frame: Baseline and 12 months
Changes in blood biomarkers
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
Time frame: Baseline, 3 months, 6 months, and 12 months
Safety: occurrence of adverse events and illnesses
Time frame: From enrollment to the end of treatment at 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started May 2026 (actual). Primary completion is estimated for Mar 2028, 22 months after the start.
Of 42 non-industry interventional studies with no phase under Hypertriglyceridemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 22 months is close to that.
Counting every sponsor, half of 45 studies reached it within 23 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Pemafibrate
Tokyo Women's Medical University