Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke

ConditionsIschemic Stroke Atherosclerosis of Artery Lipid Disorder Statin

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorXuanwu Hospital, Beijing

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will consist of hospitalized individuals diagnosed with ischemic stroke at the Stroke Center of Xuanwu Hospital. Participants will be adults aged 18 years and older who meet the inclusion criteria specified for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Statin
Drug
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.
Probucol
Drug
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Conventional Lipid-Lowering Therapy Group1 intervention

Group B: Combined Lipid-Lowering Therapy with Probucol Group1 intervention

Trial outcomes

Primary outcomes

Change in Plaque Burden from Baseline to 12-Month Follow-up

The primary outcome is the change in atherosclerotic plaque burden, measured as the percentage of stenosis at the most severe location of atherosclerotic plaque on computed tomography angiography (CTA). Plaque burden is calculated as 100% × (diameter of the plaque at its most severe point/diameter of the arterial lumen). The difference between the baseline and the 12-month follow-up measurement will be used to assess the effectiveness of the treatment.

Time frame

Baseline to 12 months

Secondary outcomes

Change in High-Risk Plaque Count from Baseline to 12-Month Follow-up

The change in the number of high-risk plaques in the coronary, aortic, and carotid arteries, assessed via CTA at the 12-month follow-up compared to baseline.

Time frame

Baseline to 12 months

Change in Atherosclerotic Burden Score from Baseline to 12-Month Follow-up

The change in the atherosclerotic burden score at 12 months, assessed through CTA imaging, compared to baseline. This score reflects the overall severity of atherosclerosis.

Time frame

Baseline to 12 months

Occurrence of Cardiovascular Events at 12-Month and 24-Month Follow-up

The incidence of composite cardiovascular events, including new fatal cardiovascular events, myocardial infarction (MI), unstable angina requiring hospitalization, and ischemic stroke (IS). Events will be reported based on whichever occurs first during the 12-month and 24-month follow-up.

Time frame

12 months and 24 months

Poor Functional Outcome at 1-Month Follow-up

The occurrence of poor functional outcomes, defined as a modified Rankin Scale (mRS) score of ≥3, assessed during the first-month visit post-treatment.

Time frame

1 month and 3 months

Other outcomes

Changes in Biomarkers from Baseline to 12-Month Follow-up

This outcome will assess the changes in various biochemical and inflammatory biomarkers from baseline to the 12-month follow-up. The biomarkers to be evaluated include: Low-Density Lipoprotein Cholesterol (LDL-C) High-Sensitivity C-Reactive Protein (hsCRP) Lipoprotein(a) \[Lp(a)\] Total Cholesterol Apolipoprotein B (ApoB) Apolipoprotein A1 (ApoA1) Other relevant biomarkers

Time frame

Baseline to 12 months

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Xuanwu HospitalRecruiting Xicheng District, Beijing Municipality China

China

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

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