Combining Probucol with Statins for Ischemic Stroke Treatment

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

This study is testing if adding Probucol to standard statin treatment can help adults who have had an ischemic stroke and have atherosclerosis by reducing plaque buildup and preventing future strokes or heart problems.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Xicheng District, Beijing Municipality)
• Trial ID: NCT06604117 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of adding Probucol to standard statin therapy in reducing plaque burden and preventing vascular events in adults who have experienced an ischemic stroke and have confirmed atherosclerosis. Participants will be assigned to either standard statin therapy or the combination of statins with Probucol, with follow-up visits over a three-year period to monitor their cardiovascular health. The study aims to determine if the combination therapy is more effective than statins alone in improving outcomes related to atherosclerosis and reducing the risk of further strokes or cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 years or older who have had an ischemic stroke within the last 30 days and have confirmed atherosclerosis.

Not a fit: Patients with non-atherosclerotic arterial stenosis or those with a history of allergy to Probucol or statins may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of further vascular events in patients with ischemic stroke and atherosclerosis.

How similar studies have performed: While the combination of Probucol and statins is a novel approach, previous studies have shown that statins alone can be effective in managing atherosclerosis, suggesting potential for success with this combination.

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 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.

Where this trial is running

Xicheng District, Beijing Municipality

• Xuanwu Hospital — Xicheng District, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jing Dong, Doctor — Xuanwu Hospital, Beijing
• Study coordinator: Xin Ma, Doctor

Conditions Ischemic Stroke; Atherosclerosis of Artery; Lipid Disorder; Statin; Probucol; Atherosclerosis; Ischemic stroke; Plaque burden