Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03552432
Other study ID # KobeU-290017
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 26, 2017
Est. completion date September 30, 2021

Study information

Verified date May 2018
Source Kobe University
Contact Hiromasa Otake, M.D, Ph,D
Phone +81-78-382-5846
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.

Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date September 30, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Patients received PCI for acute coron ary syndrome or stable angina

2. Patients had received or started after PCI statin therapy

3. OCT images could obtained and vuln erable plaques were presence

4. Patients over 20 years old

5. Written consent for participation in th e study

Exclusion Criteria:

1)Patients had one or more administration of anti-PSCK9 monoclonal Antibody 2)Patients had uncontroled hypertensio n before Visit 1 3)Patients with well controlled LDL-C:7 0mg/dl or less 4)Past medical history of hypersensitivit y to investigational drugs 5)Patients had past medical history of H emorrhagic stroke 6)Patients received Anticancer drug 7)Patients received LDL-aphelesis 8)Patienta had severe liver or renal fun ction 9)10)Patients had contraindication of in vestigational drugs 11)pregnant, lactating, and possibly pre gnant women and those planning to be come pregnant 12)judged as ineligible by clinical invest igators

Study Design


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


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



Type Measure Description Time frame Safety issue
Primary the change in fibrous cap thickness 9 month
Secondary the change in lipid index 9 month
Secondary the change in lipid length, 9 month
Secondary the change in mean lipid arc 9 month
Secondary the change in max lipid arc 9 month
Secondary the change in macrophage grade macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ?3 quadrants; and grade 4, clustered accumulation ?3 9 month
Secondary the number of thin-cap fibroatheroma 9 month
Secondary the change in lipid parameters including LDL-cholesterol, HDL-cholesterol, total-cholesterol, Lipoprotain(a) 9 month
Secondary the change in hs-CRP 9 month
Secondary the change in IL-6 9 month
Secondary the change in TNF-a 9 month
Secondary the change in MCP-1 9 month
Secondary the change in MMP-2, and MMP-9 9 month
Secondary the change in VCAM-1, and ICAM-1 9 month
See also
  Status Clinical Trial Phase
Completed NCT02115308 - Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging Phase 4
Terminated NCT01374555 - Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT03226262 - FFRangio Accuracy vs. Standard FFR
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03620539 - Sauna Bathing to Improve Vascular Health of Adults With Heart Disease N/A
Not yet recruiting NCT03427749 - Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
Recruiting NCT03518437 - Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Active, not recruiting NCT02693158 - The Direct III Post Market Study
Enrolling by invitation NCT02894255 - Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents Phase 4
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A