Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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 mg/dL) despite stable statin therapy.

Eligible patients are randomized to receive either alirocumab or standard-of-care (1:1). The last dose of alirocumab will be given at week 34. Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. OCT images will be acquired at the baseline and at week 36 ± 2 weeks follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Anzhen Hospital
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

Inclusion Criteria:

(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 Criteria:

1. Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody

2. received target vessel revascularization

3. Known hypersensitivity or have contraindications to any anti-PCSK9 monoclonal antibody or statins

4. Unable to receive OCT imaging tests

5. Known history of hemorrhagic stroke

6. Currently under treatment for cancer

7. Baseline triglyceride > 400 mg/dl

8. Patients with severe liver or renal dysfunction

9. Pregnant or breast-feeding women

10. Considered by the investigator as inappropriate for this study for any reason