NCT03552432

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

The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Kobe University · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

• Coronary Artery Disease
• Thin-cap fIbroatheroma

Interventions

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

Timeline

• Start date: 2017-08-23
• Primary completion: 2020-09-30
• Completion: 2021-09-30
• First posted: 2018-06-11
• Last updated: 2018-11-14

Locations

1 site across 1 country: Japan