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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 September 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 who underwent PCI for ACS or stable coronary heart disease

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

3. Patients who have been had TCFA detected by OCT

4. Patients aged =20 years old at PCI

5. Patients who agree to be enrolled in the trial giving signed written informed consent

Exclusion Criteria:

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

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

3. Known hypersensitivity to alirocumab or rosuvastatin

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

5. Known history of hemorrhagic stroke

6. Currently under treatment for cancer

7. Patients on lipoprotein apheresis

8. Patients with severe liver or renal dysfunction

9. Pregnant or breast-feeding women

10. Considered by the investigator as inappropriate for this study for any reason

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 the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up 9 month
Secondary the change in fibrous cap thickness the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up 9 month
Secondary the change in lipid index absolute change in lipid index between baseline and 36-week follow-up 9 month
Secondary the change in lipid index percentage change in lipid index between baseline and 36-week follow-up 9 month
Secondary the change in lipid length, absolute change in lipid core length between baseline and 36-week follow-up 9 month
Secondary the change in lipid length, percentage change in lipid core length between baseline and 36-week follow-up 9 month
Secondary the change in mean lipid arc absolute change in mean lipid arc between baseline and 36-week follow-up 9 month
Secondary the change in mean lipid arc percentage change in mean lipid arc between baseline and 36-week follow-up 9 month
Secondary the change in max lipid arc absolute change in max lipid arc between baseline and 36-week follow-up 9 month
Secondary the change in max lipid arc percent change in max lipid arc between baseline and 36-week follow-up 9 month
Secondary the change in macrophage grade absolute change in summation of macrophage grade between baseline and 36-week follow-up.
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 change in macrophage grade percentage change in summation of macrophage grade between baseline and 36-week follow-up.
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 change in minimum lumen area absolute change in minimum lumen area between baseline and 36-week follow-up 9 month
Secondary the change in minimum lumen area percentage of change in minimum lumen area between baseline and 36-week follow-up 9 month
Secondary the number of thin-cap fibroatheroma change of the number of thin-cap fibroatheroma at 36-week follow-up 9 month
Secondary the change in total cholesterol absolute change in serum level of of total cholesterol between baseline and 36-week follow-up 9 month
Secondary the change in total cholesterol percent change in serum level of of total cholesterol between baseline and 36-week follow-up 9 month
Secondary the change in LDL-C absolute change in serum level of of LDL-C between baseline and 36-week follow-up 9 month
Secondary the change in LDL-C percentage change in serum level of of LDL-C between baseline and 36-week follow-up 9 month
Secondary the change in HDL-C absolute change in serum level of of HDL-C between baseline and 36-week follow-up 9 month
Secondary the change in HDL-C percentage change in serum level of of HDL-C between baseline and 36-week follow-up 9 month
Secondary the change in non-HDL-C absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up 9 month
Secondary the change in non-HDL-C percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up 9 month
Secondary the change in apolipoprotein B absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up 9 month
Secondary the change in apolipoprotein B percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up 9 month
Secondary the change in Lp(a) absolute change in serum level of of Lp (a) between baseline and 36-week follow-up 9 month
Secondary the change in Lp(a) percentage change in serum level of of Lp (a) between baseline and 36-week follow-up 9 month
Secondary the change in hs-CRP absolute change in serum level of hs-CRP between baseline and 36-week follow-up 9 month
Secondary the change in hs-CRP percentage change in serum level of hs-CRP between baseline and 36-week follow-up 9 month
Secondary the change in IL-1ß absolute change in serum level of IL-1ß between baseline and 36-week follow-up 9 month
Secondary the change in IL-1ß percentage change in serum level of IL-1ß between baseline and 36-week follow-up 9 month
Secondary the change in IL-6 absolute change in serum level of IL-6 between baseline and 36-week follow-up 9 month
Secondary the change in IL-6 percentage change in serum level of IL-6 between baseline and 36-week follow-up 9 month
Secondary the change in TNF-a absolute change in serum level of TNF-a between baseline and 36-week follow-up 9 month
Secondary the change in TNF-a percentage change in serum level of TNF-a between baseline and 36-week follow-up 9 month
Secondary the change in MCP-1 absolute change in serum level of MCP-1 between baseline and 36-week follow-up 9 month
Secondary the change in MCP-1 percentage change in serum level of MCP-1 between baseline and 36-week follow-up 9 month
Secondary the change in MMP-2 absolute change in serum level ofMMP-2 between baseline and 36-week follow-up 9 month
Secondary the change in MMP-2 percentage change in serum level ofMMP-2 between baseline and 36-week follow-up 9 month
Secondary the change in MMP-9 absolute change in serum level of MMP-9 between baseline and 36-week follow-up 9 month
Secondary the change in MMP-9 percentage change in serum level of MMP-9 between baseline and 36-week follow-up 9 month
Secondary the change in VCAM-1 absolute change in serum level of VCAM-1between baseline and 36-week follow-up 9 month
Secondary the change in VCAM-1 percentage change in serum level of VCAM-1 between baseline and 36-week follow-up 9 month
Secondary the change in ICAM-1 absolute change in serum level of ICAM-1 between baseline and 36-week follow-up 9 month
Secondary the change in ICAM-1 percentage change in serum level of ICAM-1 between baseline and 36-week follow-up 9 month
Secondary the change in free PCSK9 absolute change in serum level of free PCSK9 between baseline and 36-week follow-up 9 month
Secondary the change in free PCSK9 percentage change in serum level of free PCSK9 between baseline and 36-week follow-up 9 month
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