Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke

Launched by XUANWU HOSPITAL, BEIJING · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a medication called Probucol to standard cholesterol-lowering treatment (statins) can help reduce the risk of further blood vessel problems in adults who have recently had an ischemic stroke, which occurs when blood flow to the brain is blocked. Researchers want to find out if this combination therapy is better at lowering plaque buildup in arteries and preventing future cardiovascular issues compared to using statins alone.

To be eligible for the trial, participants must be at least 18 years old, have had an ischemic stroke within the last 30 days, and show signs of artery disease. Those who join the study will either receive standard statin therapy or the same therapy with Probucol added. Participants will have regular check-ups over three years to monitor their heart health and the state of their arteries through imaging tests and blood tests. It's important to know that some individuals, such as those with certain health conditions or who are pregnant, may not be able to participate.

Gender

ALL

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.