Status:
RECRUITING
Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Ischemic Stroke
Atherosclerosis of Artery
Eligibility:
All Genders
18+ years
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 ischem...
Detailed Description
This single-center, prospective, open-label study will assess the effects of combining Probucol with statin therapy on the progression of atherosclerosis and the risk of vascular events in people with...
Eligibility Criteria
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
- 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.
- Known bleeding tendencies or hemorrhagic diseases, such as thrombocytopenia (platelet count \< 100 × 10\^9/L), hemorrhagic stroke, or gastrointestinal bleeding.
- Severe myocardial diseases such as myocardial infarction (MI) or myocarditis.
- 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.
- Ventricular tachycardia, bradycardia, torsades de pointes, or syncopal episodes of cardiac origin.
- Prolonged QT interval or conditions that may prolong the QT interval, such as certain medications.
- Suffering from a severe illness with a life expectancy of less than one year or unable to cooperate due to cognitive or psychological issues.
- 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.
- Pregnant or breastfeeding individuals, those trying to conceive.
- 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.
- Any reason, known to the participant and investigator, that would prevent the participant from adhering to the study protocol or follow-up.
- Other conditions determined by the investigator that may require exclusion.
Key Trial Info
Start Date :
October 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06604117
Start Date
October 17 2024
End Date
October 1 2027
Last Update
March 25 2025
Active Locations (1)
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1
Xuanwu Hospital
Xicheng District, Beijing Municipality, China