Actively Recruiting
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
Led by First Affiliated Hospital of Xinjiang Medical University · Updated on 2024-08-19
396
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.
CONDITIONS
Official Title
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18-55 years and women aged 18-65 years
- Coronary artery disease patients with angiographically confirmed lesions in two or more vessels
- At least one vessel with critical disease causing 50-70% narrowing
- LDL cholesterol above 3.4 mmol/L without regular statin treatment or above 1.8 mmol/L after 4 weeks of statin therapy
You will not qualify if you...
- Known allergies or contraindications to PCSK9 inhibitors or statin therapy
- Prior use of PCSK9 inhibitors
- History of hemorrhagic stroke
- Previous coronary artery bypass grafting or coronary intervention
- Unable to undergo clear optical coherence tomography imaging
- Severe kidney failure with creatinine clearance below 30 mL/min
- Severe liver dysfunction
- Baseline triglycerides above 5.6 mmol/L
- Pregnant or breastfeeding women
- Life expectancy less than 1 year
- Deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830011
Actively Recruiting
Research Team
S
Sen Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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