Change in Plaque Characteristics With Atorvastatin (EASY-FIT)

Wakayama Medical University

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome; Dyslipidemia; Atherosclerosis

Treatments: Drug: low-dose atorvastatin; Drug: high-dose atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00700037

wakayamamu08-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

1

Experimental group

Description:

Atorvastatin 20mg

Treatment:

Drug: high-dose atorvastatin

2

Active Comparator group

Description:

atorvastatin 5mg

Treatment:

Drug: low-dose atorvastatin