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Change in Plaque Characteristics With Atorvastatin

Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00700037
Acronym
EASY-FIT
Enrollment
70
Registered
2008-06-18
Start date
2009-08-31
Completion date
2012-02-29
Last updated
2014-10-29

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

Conditions

Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia

Brief summary

To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.

Detailed description

Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of \>25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.

Interventions

DRUGlow-dose atorvastatin

5mg/day

Sponsors

Wakayama Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI. * plasma LDL cholesterol levels : \>=100mg/dL and ≤160mg/dL * at least one atherosclerotic lesion of \>25% stenosis other than culprit lesions of current ACS

Exclusion criteria

* Patients who will undergo coronary bypass surgery. * Patients with major complications during treatment of culprit coronary lesions. * Patients with an atherosclerotic lesion with \>50% stenosis at a left main trunk.

Design outcomes

Primary

MeasureTime frame
Fibrous cap thickness by OCT12 months

Secondary

MeasureTime frame
macrophage number12 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026