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Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy

Not Applicable
Recruiting
Conditions
Ischemic Heart Disease
Registration Number
JPRN-UMIN000040318
Lead Sponsor
Gifu Heart Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

(i) Patients with ST-elevated myocardial infarction (ii) Chronic renal disease manifested by estimated glomerular filtration rate of less than 40 ml/min/1.73 m2 (iii) Any clinically significant abnormality identified at screening visit, physical examination, laboratory tests, or comorbidities, which, in the judgment of the investigator, would preclude safe completion of the study (to continue LLTs or perform a follow-up NIRS-IVUS).

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare administration of PCSK9i with statin-medication on coronary plaque components in patients with CAD using gray-scale- and NIRS- derived measurement
Secondary Outcome Measures
NameTimeMethod
To compare administration of PCSK9i with statin-medication on biomarker profiles
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