NCT06604117 Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke
| NCT ID | NCT06604117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2027-10 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older. 2. Diagnosed with ischemic stroke (IS) confirmed by cranial CT/MRI. 3. Onset of stroke within the last 30 days. 4. 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. 5. Signed informed consent. Exclusion Criteria: 1. History of allergy to Probucol or statins. 2. Non-atherosclerotic arterial stenosis, such as vasculitis, moyamoya disease, or arterial dissection. 3. Potential cardiac embolic sources, such as atrial fibrillation, artificial heart valves, endocarditis, or patent foramen ovale. 4. Known bleeding tendencies or hemorrhagic diseases, such as thrombocytopenia (platelet count \< 100 × 10\^9/L), hemorrhagic stroke, or gastrointestinal bleeding. 5. Severe myocardial diseases such as myocardial infarction (MI) or myocarditis. 6. Liver (ALT or AST \> twice the upper limit
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