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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040318
Enrollment
50
Registered
2020-05-07
Start date
2018-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Interventions

None listed

Sponsors

Gifu Heart Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who had received CAG and NIRS-IVUS for ACS or chronic coronary syndrome (CCS). Patients were required to have been treated with stable LLTs (including no drug medication) for at least 4 weeks before enrollment into the present study and to have an LDL-C level of more than 80 mg/dl at baseline NIRS-IVUS.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
To compare administration of PCSK9i with statin-medication on coronary plaque components in patients with CAD using gray-scale- and NIRS- derived measurement

Secondary

MeasureTime frame
To compare administration of PCSK9i with statin-medication on biomarker profiles

Countries

Japan

Contacts

Public ContactHideaki Ota

Gifu Heart Center Department of Cardiology

ota@heart-center.or.jp058-277-2277

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026