Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
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.
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 included those who are (I) at least 18 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.

 The study included a 36-week open-label treatment period (including post-treatment OCT
 imaging), starting within 4 weeks of baseline coronary angiogram. During the open-label
 treatment period, 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. Statin dose escalation
 or adding concomitant non-statin lipid-lowering therapy would be considered by their
 responsible physician to achieve an LDL-C target <100 mg/dL. Antithrombotic therapy and other
 concomitant medications are exclusively decided by the responsible physicians. Follow-up
 coronary angiograms and OCT imaging analyses of the same vessels will be carried out at the
 end of treatment period (at week 36 ± 2 weeks, depending on patient availability) in both
 study arms. Regular medical examination and laboratory tests will be conducted at weeks 4,
 12, 24, and 36. All enrolled patients are monitored and evaluated for safety and any other
 adverse events during the study period.
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