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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
Email hotake@med.kobe-u.ac.jp
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


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.


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


Intervention

Drug:
Alirocumab
the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus 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 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
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