Tests probucol added to statins in people with ischemic stroke

Trial details

Who runs it

Xuanwu Hospital, Beijing

Trial code

NCT06604117

Record updated

25 March 2025

Original description

The goal of this clinical trial is to evaluate whether the combination of Probucol with statin therapy can reduce the risk of vascular events and improve atherosclerosis outcomes in adults with ischemic stroke and confirmed atherosclerosis. The main questions it aims to answer are:Read full original descriptionShow less

A Prospective, Open-label Study Evaluating the Effects of Probucol Combined with Statins on Atherosclerotic Characteristics and Prognosis in Patients with Ischemic Stroke

The goal of this clinical trial is to evaluate whether the combination of Probucol with statin therapy can reduce the risk of vascular events and improve atherosclerosis outcomes in adults with ischemic stroke and confirmed atherosclerosis. The main questions it aims to answer are:

Does adding Probucol to statin therapy reduce plaque burden more effectively than statins alone? Does the combination therapy lead to fewer cardiovascular and cerebrovascular events compared to statins alone? Researchers will compare participants receiving standard statin therapy to those receiving statins combined with Probucol to assess differences in plaque burden and the occurrence of vascular events.

Participants will:

Choose either standard statin therapy (with possible addition of ezetimibe or PCSK9 inhibitors) or the same therapy combined with Probucol 0.5g twice daily.

Attend regular follow-up visits for monitoring atherosclerosis features and cardiovascular health over a 3-year period.

Undergo imaging studies to evaluate changes in atherosclerosis and blood tests to monitor lipid levels and other biomarkers.

Inclusion: Aged 18 years or older; Diagnosed with ischemic stroke (IS) confirmed by cranial CT/MRI; Onset of stroke within the last 30 days; Evidence of atherosclerosis (AS) in at least one artery (carotid, coronary, aorta, renal, or peripheral arteries) identified through neck CTA, coronary CTA, or ultrasound examination of lower extremity arteries; Signed informed consent.

Exclusion: Use of Probucol or any lipid-lowering medication other than statins, ezetimibe, and PCSK9 inhibitors within the 30 days prior to enrollment, including bile acid sequestrants, fibrates, and other similar drugs; Concurrent participation in another clinical trial involving investigational drugs or devices within the past 30 days; Planned surgery or intervention that would require discontinuation of the study medication during the study period; History of allergy to Probucol or statins; Non-atherosclerotic arterial stenosis, such as vasculitis, moyamoya disease, or arterial dissection; Potential cardiac embolic sources, such as atrial fibrillation, artificial heart valves, endocarditis, or patent foramen ovale; Severe myocardial diseases such as myocardial infarction (MI) or myocarditis; Ventricular tachycardia, bradycardia, torsades de pointes, or syncopal episodes of cardiac origin; Suffering from a severe illness with a life expectancy of less than one year or unable to cooperate due to cognitive or psychological issues; Other conditions determined by the investigator that may require exclusion; Known bleeding tendencies or hemorrhagic diseases, such as thrombocytopenia (platelet count \< 100 × 10\^9/L), hemorrhagic stroke, or gastrointestinal bleeding; Liver (ALT or AST \> twice the upper limit of normal) or kidney (creatinine \> 1.5 times the upper limit of normal or glomerular filtration rate \< 50 ml/min) dysfunction; Prolonged QT interval or conditions that may prolong the QT interval, such as certain medications; Pregnant or breastfeeding individuals, those trying to conceive; Any reason, known to the participant and investigator, that would prevent the participant from adhering to the study protocol or follow-up.

ClinicalTrials.gov NCT06604117