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RECRUITING

NCT06604117

Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-10-17

Completion Date

2027-10

Last Updated

2025-03-25

Healthy Volunteers

Conditions

Ischemic Stroke Atherosclerosis of Artery Lipid Disorder Statin

Interventions

DRUG

Statin

Participants who opt for this group will receive guideline-recommended conventional lipid-lowering therapy. For those with a history of ischemic stroke (IS), myocardial infarction (MI), acute coronary syndrome within the past year, symptomatic peripheral artery disease, or two or more high-risk factors, the target LDL-C level will be set at 1.4 mmol/L. For other IS participants, the LDL-C target will be set at 1.8 mmol/L. All participants will receive moderate-intensity statin therapy as the primary treatment. If LDL-C levels are not adequately controlled, ezetimibe will be added. If lipid levels remain unsatisfactory, the addition of PCSK9 inhibitors will be considered. Moderate-intensity statins are defined as atorvastatin 10-20 mg or rosuvastatin 5-10 mg.

DRUG

Probucol

Participants who choose this group will receive Probucol in combination with guideline-recommended lipid-lowering therapy. Specifically, participants in this group will take 0.5 grams of Probucol twice daily alongside the conventional lipid-lowering therapy mentioned in Group 1. The combination of Probucol and conventional therapy aims to further improve lipid profile and address atherosclerosis.

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 of normal) or kidney (creatinine \> 1.5 times the upper limit of normal or glomerular filtration rate \< 50 ml/min) dysfunction. 7. Ventricular tachycardia, bradycardia, torsades de pointes, or syncopal episodes of cardiac origin. 8. Prolonged QT interval or conditions that may prolong the QT interval, such as certain medications. 9. Suffering from a severe illness with a life expectancy of less than one year or unable to cooperate due to cognitive or psychological issues. 10. 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. 11. Pregnant or breastfeeding individuals, those trying to conceive. 12. Concurrent participation in another clinical trial involving investigational drugs or devices within the past 30 days. 13. Planned surgery or intervention that would require discontinuation of the study medication during the study period. 14. Any reason, known to the participant and investigator, that would prevent the participant from adhering to the study protocol or follow-up. 15. Other conditions determined by the investigator that may require exclusion.

Locations (1)

Xuanwu Hospital

Xicheng District, Beijing Municipality, China