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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-23

Study Completion Date

2021-09-30

Brief Summary

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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

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Detailed Description

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The investigators investigate to evaluate the efficacy of alirocumab for vulnerable plaque. The investigators enrolled the patient with standard statin therapy who were detected vulnerable plaque by optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin were categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. The investigators compare these two group for outcomes.

Conditions

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Coronary Artery Disease Thin-cap fIbroatheroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alirocumab therapy group

start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

standard statin therapy group

start with only rosuvastatin 10mg per day

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alirocumab

the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No