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

NCT03529253 | Unknown Phase 4 DMC

• 1 other identifier: 290068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Angina Pectoris

Keywords

Alirocumab; NIRS-IVUS; LCBI

Outcome Measures

Primary Outcomes (1)

• maxLCBI (4mm)

  baseline and 9 months

Secondary Outcomes (3)

• change amount of LCBI(lesion)

  baseline and 9 months

• change amount of Angle of lipid core

  baseline and 9 months

• change amount of LDL-Cholesterol level

  baseline and 9 months

Study Arms (2)

Intensive therapy group

EXPERIMENTAL

Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.

Drug: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily

Standard therapy group

ACTIVE COMPARATOR

The standard therapy group is Rosuvastatin10mg/daily alone.

Drug: Rosuvastatin calcium10mg

Interventions

Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily DRUG

Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.

Intensive therapy group

Rosuvastatin calcium10mg DRUG

Rosuvastatin10mg/daily by oral for 9 months.

Standard therapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hiromasa Otake, MD, PhD

CONTACT

078-382-5846; hotake@med.kobe-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior lecturer

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: April 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

JP (1)