Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT03552432
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03552432
Study Brief:
Protocol Section:
NCT03552432