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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Xuanwu Hospital
RECRUITING
Xicheng District
Contact Information
Primary
Xin Ma, Doctor
maxin@xwh.ccmu.edu.cn
+86 13501390691
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2027-10
Participants
Target number of participants: 200
Treatments
Conventional Lipid-Lowering Therapy Group
Participants who choose this group will receive conventional lipid-lowering therapy following current clinical guidelines, which may include statins, ezetimibe, or PCSK9 inhibitors. The treatment regimen will be tailored to the participants' individual needs but will not include Probucol.
Combined Lipid-Lowering Therapy with Probucol Group
Participants who choose this group will receive a combination of conventional lipid-lowering therapy following current clinical guidelines (statins, ezetimibe, or PCSK9 inhibitors) and additional treatment with Probucol 0.5g twice daily. This regimen aims to further reduce atherosclerotic plaque burden and improve cardiovascular outcomes.
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov