Total Atherosclerosis Burden of Baroreceptor-Resident Arteries Independently Predicts Blood Pressure Dipping in Patients With Ischemic Stroke.
Qi Kong, Xin Ma, Chen Wang...
https://pubmed.ncbi.nlm.nih.gov/32336234Actively Recruiting
Age: 18Years +
All Genders
ID06604117
Effects of Probucol Combined with Statins on Atherosclerosis and Prognosis in Ischemic Stroke Patients
Led by Xuanwu Hospital, Beijing · Updated on 2025-03-25
200
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether combining Probucol with statin therapy can better reduce vascular event risks and improve atherosclerosis outcomes in adults who have had an ischemic stroke and confirmed atherosclerosis. This prospective, open-label study investigates if adding Probucol to guideline-recommended statin therapy decreases plaque burden and lowers the chance of cardiovascular and cerebrovascular events compared to statins alone. Participants will either receive standard lipid-lowering therapy based on current guidelines, which may include statins, ezetimibe, or PCSK9 inhibitors, or the same therapy combined with Probucol 0.5 grams twice daily. The study will include at least 100 participants in each group and follow them over a period of three years to monitor effects on atherosclerosis progression and vascular outcomes. During the study, participants will attend regular follow-up visits to assess changes in plaque burden and atherosclerotic features through imaging studies and blood tests. Researchers will measure lipid levels and biomarkers such as LDL-C, Ox-LDL, and Lp(a), while monitoring for cardiovascular events and safety outcomes. The primary measurement is the change in plaque burden from baseline to 12 months, with additional assessments at 1, 12, and 24 months to evaluate functional outcomes and vascular event occurrence.
CONDITIONS
Brief Title
Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with ischemic stroke confirmed by cranial CT or MRI
- Stroke onset within the last 30 days
- Evidence of atherosclerosis in at least one major artery (carotid, coronary, aorta, renal, or peripheral arteries) verified by imaging
- Signed informed consent
You will not qualify if you...
- Allergy to Probucol or statins
- Non-atherosclerotic arterial stenosis like vasculitis, moyamoya disease, or arterial dissection
- Potential cardiac embolic sources such as atrial fibrillation, artificial heart valves, endocarditis, or patent foramen ovale
- Known bleeding disorders including thrombocytopenia, hemorrhagic stroke, or gastrointestinal bleeding
- Severe myocardial diseases like myocardial infarction or myocarditis
- Liver or kidney dysfunction above specified laboratory thresholds
- Ventricular tachycardia, bradycardia, torsades de pointes, or cardiac syncope
- Prolonged QT interval or conditions causing QT prolongation
- Severe illness with life expectancy under one year or cognitive/psychological inability to cooperate
- Use of lipid-lowering medications other than statins, ezetimibe, or PCSK9 inhibitors within 30 days prior
- Pregnant, breastfeeding, or trying to conceive
- Participation in another investigational drug or device trial within the past 30 days
- Planned surgery or intervention requiring stopping study medication
- Any condition preventing protocol adherence or follow-up
- Other investigator-determined exclusion reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive either conventional lipid-lowering therapy following clinical guidelines or a combination of conventional therapy with Probucol 0.5g twice daily to reduce atherosclerotic plaque burden and improve cardiovascular outcomes.
Visits as per treatment monitoring schedule
Follow-up
Duration - Up to 12 additional months after treatment
Participants are monitored for cardiovascular events, stroke recurrence, and functional outcomes after treatment ends.
Visits at 12 months and 24 months follow-up
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital
Xicheng District, Beijing Municipality, China
Actively Recruiting
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Research Team
X
Xin Ma, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Integrated Analysis of Two Probucol Trials for the Secondary Prevention of Atherosclerotic Cardiovascular Events: PROSPECTIVE and IMPACT.
Hidenori Arai, Hideaki Bujo, Daisaku Masuda...
https://pubmed.ncbi.nlm.nih.gov/33867420Probucol attenuates inflammation and increases stability of vulnerable atherosclerotic plaques in rabbits.
Tingting Li, Wenqiang Chen, Fengshuang An...
https://pubmed.ncbi.nlm.nih.gov/21852751Probucol protects lipoprotein (a) against oxidative modification.
M Naruszewicz, E Selinger, R Dufour...
https://pubmed.ncbi.nlm.nih.gov/1435295Protective effects of probucol on Ox-LDL-induced epithelial-mesenchymal transition in human renal proximal tubular epithelial cells via LOX‑1/ROS/MAPK signaling.
Bing Bing Zhu, Hao Wang, Yang Feng Chi...
https://pubmed.ncbi.nlm.nih.gov/29115480Oxidized low-density lipoprotein and atherosclerosis implications in antioxidant therapy.
Sona Mitra, Abhishek Deshmukh, Rajesh Sachdeva...
https://pubmed.ncbi.nlm.nih.gov/21747278Lipoprotein(a) and its Significance in Cardiovascular Disease: A Review.
Freddy Duarte Lau, Robert P Giugliano
https://pubmed.ncbi.nlm.nih.gov/35583875The changing landscape of atherosclerosis.
Peter Libby
https://pubmed.ncbi.nlm.nih.gov/338837282021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association.
Dawn O Kleindorfer, Amytis Towfighi, Seemant Chaturvedi...
https://pubmed.ncbi.nlm.nih.gov/34024117PCSK9 inhibitors and ezetimibe with or without statin therapy for cardiovascular risk reduction: a systematic review and network meta-analysis.
Safi U Khan, Siva H Yedlapati, Ahmad N Lone...
https://pubmed.ncbi.nlm.nih.gov/35508321