Symptomatic intracranial arterial stenosis with hypertriglyceridemia Intracranial Arterial Diseases, Hypertriglyceridemia
Conditions
Interventions
This study will involve an intervention comparing patients receiving pemafibrate with those not receiving the drug. All other examinations and observations will be conducted as part of routine clinica
C000601841
Sponsors
Todo Kenichi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints (supplementary analyses of the primary endpoint): - Change in intracranial arterial stenosis on CTA at 12 months from enrollment (three categories: progression, no change, improvement) - Improvement in intracranial arterial stenosis on CTA at 12 months from enrollment (improvement vs. no improvement [progression or no change]) Other secondary endpoints: - Change in percent stenosis by the WASID method - Proportion of intracranial arterial stenosis progression/improvement per the TOSS and TOSS-2 criteria - Proportion of intracranial arterial stenosis progression/improvement per the Wong KS criteria - 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) 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 All-cause mortality - Activities of daily living by mRS score (mRS 0-1, 0-2, and 0-3 proportions, and the overall mRS score distribution) - Changes in cerebral small vessel disease on brain MRI (Fazekas scale, cerebral microbleeds, total SVD score) - Changes in ABI, CAVI, and PWV - 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 - Safety: occurrence of adverse events and illnesses | — |
Contacts
Public ContactTakao Hoshino
Department of Neurology, Tokyo Women's Medical University Hospital
Outcome results
None listed