Triglyceride-lowering Therapy With Pemafibrate for Prevention of Atherosclerotic Cardiovascular Disease in Patients With Symptomatic Intracranial Artery Stenosis: a Multi-center, Open-label, Randomized Controlled Trial (PPAR-ICAS)

What this Trial Is About

Researchers are evaluating whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in adults who have symptomatic ICAS and high triglyceride levels after ischemic stroke or transient ischemic attack (TIA). The study aims to determine if pemafibrate reduces ICAS progression over 12 months, improves triglyceride levels and other vascular risk markers, and affects vascular events, functional outcomes, and safety during this period. This is an open-label, randomized trial comparing pemafibrate plus standard stroke care to standard care alone. Participants will be randomly assigned to receive either pemafibrate along with standard medical therapy or standard medical therapy without pemafibrate. Those in the pemafibrate group will take the drug for 12 months, with possible dose adjustments based on triglyceride levels and kidney function. Both groups will continue their usual stroke treatments, including antithrombotic therapy and management of other risk factors such as blood pressure and diabetes. Participants will have blood tests and clinical assessments at the start and during follow-up, including brain CT angiography (CTA) at baseline and 12 months. Additional imaging and vascular tests, such as brain MRI/MRA, ankle brachial index, cardio ankle vascular index, and pulse wave velocity, will be performed according to the study schedule. The research team will monitor vascular events, daily functioning, adverse events, and safety throughout the one-year study period.

Pemafibrate for Symptomatic ICAS RCT