Study of Pemafibrate to Prevent Worsening of Intracranial Artery Narrowing in Adults with Symptomatic Intracranial Artery Stenosis and High Triglycerides

What this Trial Is About

Researchers are studying whether pemafibrate can help prevent worsening of intracranial arterial stenosis ICAS in adults who have symptomatic ICAS and high triglyceride levels following an ischemic stroke or transient ischemic attack TIA. This open-label, randomized, parallel-group trial compares participants receiving pemafibrate with those receiving standard care without pemafibrate to evaluate its effects on ICAS progression, triglyceride levels, vascular risk markers, vascular events, functional outcomes, and safety over 12 months. Participants will be randomly assigned to either a group receiving pemafibrate plus standard medical therapy or a group receiving standard therapy alone. Those in the pemafibrate group will take the medication for 12 months, with dose adjustments possible based on triglyceride levels and kidney function. Both groups will continue standard stroke care, including treatments for blood pressure, cholesterol, diabetes, and smoking. Brain CT angiography CTA will be performed at the start of the study and after 12 months. Additional imaging and vascular tests like brain MRIMRA, ankle brachial index, cardio ankle vascular index, and pulse wave velocity will follow the study schedule. Throughout the year-long study, participants will have blood tests and clinical assessments at baseline and during follow-up visits. Researchers will monitor vascular events, functional outcomes using scales such as the modified Rankin Scale, and adverse events. Changes in intracranial arterial stenosis on CTA are the main outcome measured at baseline and 12 months. Safety and multiple vascular and imaging markers will be evaluated at various points. Participants will be followed closely for one year to assess the effects and safety of pemafibrate in this population.

Pemafibrate for Symptomatic ICAS RCT