Status:
RECRUITING
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
Lead Sponsor:
First Affiliated Hospital of Xinjiang Medical University
Conditions:
Coronary Artery Disease
Optical Coherence Tomography
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 inhibit...
Detailed Description
Following initial percutaneous coronary intervention (PCI) for culprit lesions in patients with early-onset coronary artery disease (CAD) and ≥2 additional lesions meeting baseline lipid criteria, opt...
Eligibility Criteria
Inclusion
- Men aged 18-55 years and women aged 18-65 years;
- CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);
- LDL-C \>3.4 mmol/L without regular statin therapy or LDL-C \>1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
Exclusion
- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
- Prior use of PCSK9 inhibitors;
- Prior history of hemorrhagic stroke;
- Prior coronary artery bypass grafting or coronary intervention;
- Inability to perform OCT imaging or unclear imaging;
- Severe renal insufficiency (creatinine clearance \< 30 mL/min);
- Severe hepatic dysfunction;
- Baseline triglycerides \> 5.6 mmol/L;
- Pregnant or lactating women;
- Life expectancy not exceeding 1 year;
- In the judgment of the investigator, unsuitable for this study for any reason.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT06520904
Start Date
July 1 2024
End Date
December 31 2026
Last Update
August 19 2024
Active Locations (1)
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1
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830011