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Effect of statin with ezetimibe versus statin alone on progression of coronary atherosclerotic plaque: Evaluate by Intravasclular ultrasound Virtual Histology and Optical Coherence Tomography

Effect of statin with ezetimibe versus statin alone on progression of coronary atherosclerotic plaque: Evaluate by Intravasclular ultrasound Virtual Histology and Optical Coherence Tomography - ZEST registry

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005563
Enrollment
100
Registered
2011-05-07
Start date
2009-04-01
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

One year Fluvastatin (30mg) and Ezetimibe (10mg) One year Fluvastatin (30mg) alone

Sponsors

Toyohashi Heart Ceter, Cardiovascular Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Stable angina pectoris 2) All patients have 1 or 2-vessel diseases and were good candidates for percutaneous coronary intervention. 3) Target vessel for VH IVUS and OCT interrogation must not have undergone angioplasty or have more than 50% luminal narrowing throughout a target segment with a minimum length of 30mm 4) Target vessel for VH IVUS and OCT interrogation had mild-to-moderate vessel tortuosity and calcification 5) Left ventricular ejection fraction >30%

Exclusion criteria

Exclusion criteria: 1) Unstable angina or myocardial infarction within the previous 4 weeks 2) Significant stenotic lesions in all coronary vessels 3) Target vessel for VH IVUS and OCT interrogation had lesions with angiographically detected thrombus 4) Contra-indications to IVUS and OCT examination 5) Other concomitant diseases or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis,stroke, or transient ischemic neurological attacks within the past year or hypersensitivity to heparin, aspirin, ticlopidine, or X-ray contrast media 6) Secondary causes of hyperlipid-emia or uncontrolled triglyceride level above 500 mg/dl 7) A positive pregnancy test.

Design outcomes

Primary

MeasureTime frame
OCT and VH IVUS findings at one year. 1. Thickness of fibrous cap in OCT 2. %necrotic core volume in VH 3. the incidence of thin-cap fibroatheroma in OCT and VH findings

Countries

Japan

Outcome results

None listed

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