The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

• Status: Unknown status
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration

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

Details

• Lead Sponsor: Kobe University
• Treatments: Antibodies, Monoclonal; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Patients who underwent PCI for ACS or stable coronary heart disease

2. Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin

3. Patients who have been had TCFA detected by OCT

4. Patients aged ≥20 years old at PCI

5. Patients who agree to be enrolled in the trial giving signed written informed consent

Exclusion Criteria:

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

2. Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit

3. Known hypersensitivity to alirocumab or rosuvastatin

4. All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments

5. Known history of hemorrhagic stroke

6. Currently under treatment for cancer

7. Patients on lipoprotein apheresis

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