Condition: Intracranial Atherosclerotic Disease (ICAD) · Hypertriglyceridaemia · Stroke (CVA) or TIA · Sponsor: Tokyo Women's Medical University
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. Does pemafibrate lower the chance that ICAS gets worse over 12 months? 2. Does pemafibrate improve TG levels and other vascular risk markers? 3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months? 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-ather…
This description comes directly from the study's public registry record.
Kenichi Todo, MD, PhD · +81-3-3353-8111 · todo.kenichi@twmu.ac.jp
Takao Hoshino, MD, PhD · +81-3-3353-8111 · hoshino.takao@twmu.ac.jp
Always discuss trial participation with your own doctor first.
| Iwate Medical University Hospital | Hizume, Iwate, Japan | Recruiting |
| Kagoshima Medical Center | Kagoshima, Kagoshima-ken, Japan | Recruiting |
| Kumamoto University Hospital | Kumamoto, Kumamoto, Japan | Recruiting |
| Japanese Red Cross Kyoto Daini Hospital | Kyoto, Kyoto, Japan | Recruiting |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto, Kyoto, Japan | Recruiting |
| Nagasaki University Hospital | Nagasaki, Nagasaki, Japan | Not Yet Recruiting |
| Kawasaki Medical School Hospital | Kurashiki, Okayama-ken, Japan | Recruiting |
| Kansai Medical University Hospital | Hirakata, Osaka, Japan | Recruiting |
| Osaka National Hospital | Osaka, Osaka, Japan | Recruiting |
| Osaka General Medical Center | Osaka, Osaka, Japan | Recruiting |
| Saitama Medical University International Medical Center | Hidaka, Saitama, Japan | Not Yet Recruiting |
| Japanese Red Cross Saitama Hospital | Saitama, Saitama, Japan | Not Yet Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07562178