Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound

Coronary Artery Disease Clinical Trial

— ANTARES  

Official title:

Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03529253
• Other study ID #: 290068
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2018
• Source: Kobe University
• Contact: Hiromasa Otake, MD, PhD
• Phone: 078-382-5846
• Email: hotake[@]med.kobe-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.

Description:

The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent PCI for ACS or stable coronary heart disease

• Patients with LDL-C =70 mg/dL under daily 10mg rosuvastatin

• Patients who remained 25-75% stenosis with coronary angiography

• Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS

• Patients aged =20 years old at PCI

• Patients who agree to be enrolled in the trial give signed written informed consent

Exclusion Criteria:

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

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

• Known hypersensitivity to alirocumab or rosuvastatin

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

• Known history of hemorrhagic stroke

• Currently under treatment for cancer

• Patients on lipoprotein apheresis

• Patients with severe liver or renal dysfunction

• Pregnant or breastfeeding women

• Patients recognized as inadequate by attending physician

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily
Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.
• Rosuvastatin calcium10mg
Rosuvastatin10mg/daily by oral for 9 months.

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine, Department of Cardiology	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maxLCBI (4mm)		baseline and 9 months
Secondary	change amount of LCBI(lesion)		baseline and 9 months
Secondary	change amount of Angle of lipid core		baseline and 9 months
Secondary	change amount of LDL-Cholesterol level		baseline and 9 months