Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound

Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound - eZetimibe clinical investigation for the regression of Intracoronary Plaque evaluated by ANGioscopy and Ultrasound(ZIPANGU study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006971

Enrollment

130

Registered

2011-12-28

Start date

2011-11-01

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

Coronary artery disease with dyslipidemia

Interventions

Conventional treatment Atorvastatin 10-20mg/day Additional treatment Atorvastatin 10-20mg/day + ezetimibe 10mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing elective PCI and have yellow plaques(grade 2-4) fulfilled following inclusion criteria 1)Taking statin or LDL-C>=100mg/dL without statin 2)Age:20-80(as a general rule), men and women 3)Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients have hypersensitivity to test medicines 2) triglyceride>=400mg/dL 3) Patients with severe liver/renal disease(AST and/or ALT is as thrice as standard value/ dialysis, serum creatinine>2.0mg/dL and/or CK>500IU/L) 4) HbA1c>=8% (JDS, >=8.4% in NGSP) or taking administration of insulin 5) Patients with ACS(AMI, unstable angina) histories within 3 months 6) Patients with secondary hyperlipidemia or drug induced hyperlipidemia 7) Patients diagnosed malignancy 8) Patients with familial hypercholesterolemia 9) Pregnant,breast-feeding, becoming pregnant 10) treatment with cyclosporine 11) inadequate to this study

Design outcomes

Primary

Measure	Time frame
Yellow grade and volume of atherosclerotic plaques assessed by angioscopy and IVUS	—

Secondary

Measure	Time frame
1. Characteristics of atherosclerotic plaques assessed by IB-IVUS 2. Changes of lipid metabolism, gluco metabolism, bio markers (adiponectin, hs-CRP) cholesterol synthesis/absorption markers 3. Rate of Cardiovascular events 4. Rate of Adverse events	—

Countries

Japan

Outcome results

None listed

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