Status:
COMPLETED
Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Randomized Controlled Trials
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The study is a prospective, open-label, randomized, single-center study involving patients with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C values (LDL-C≥100 ...
Detailed Description
The study is a prospective, open-label, randomized, single-center study involving patients with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C values (LDL-C≥100 ...
Eligibility Criteria
Inclusion
- (I) 18 - 80 years of age, (II) diagnosed as stable coronary artery disease or acute coronary syndrome during admission (III) undergoing clinically indicated coronary angiography and identified with at least one intermediate lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for 2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide written, informed consent.
Exclusion
- Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
- received target vessel revascularization
- Known hypersensitivity or have contraindications to any anti-PCSK9 monoclonal antibody or statins
- Unable to receive OCT imaging tests
- Known history of hemorrhagic stroke
- Currently under treatment for cancer
- Baseline triglyceride \> 400 mg/dl
- Patients with severe liver or renal dysfunction
- Pregnant or breast-feeding women
- Considered by the investigator as inappropriate for this study for any reason
Key Trial Info
Start Date :
March 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04851769
Start Date
March 2 2019
End Date
March 1 2021
Last Update
April 20 2021
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029