Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.

UMIN ID: UMIN000029533

Registered date:13/10/2017

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: vulnerable plaque in patients with coronary artery disease
• Date of first enrollment: 2017/09/26
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients in the alirocumab arm will receive subcutaneous alirocumab 75 mg every 2 weeks (Q2W) in addition to statin therapy (rosuvastatin 10 mg/day).
Patients in the standard-of-care arm will receive rosuvastatin 10 mg/day, with initiation and/or dose adjustment of non-statin lipid-lowering drugs to achieve an LDL-C target <70 mg/dL

Outcome(s)

• Primary Outcome: the difference of fibrous cap thickness from baseline

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion criteria are follows; 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: Patients with LDL-C <70 mg/dL 4: Known hypersensitivity to alirocumab or rosuvastatin 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: All contraindications to rosuvastatin as displayed in the respective national product labeling for these treatments 10: All contraindications to alirocumab as displayed in the respective national product labeling for these treatments 11: Pregnant or breast-feeding women 12: Considered by the investigator as inappropriate for this study for any reason

Related Information

• Primary Sponsor: Kobe University Graduate School of Medicine
• Source(s) of Monetary Support: Kobe University Graduate School of Medicine