Change in Plaque Characteristics With Atorvastatin

Phase 4

Completed

• Conditions: Atherosclerosis; Acute Coronary Syndrome; Dyslipidemia
• Interventions: Drug: high-dose atorvastatin; Drug: low-dose atorvastatin

• Registration Number: NCT00700037
• Lead Sponsor: Wakayama Medical University

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.

Study Timeline

• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-18
• Study Start: 2009-08
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	high-dose atorvastatin	Atorvastatin 20mg
2	low-dose atorvastatin	atorvastatin 5mg

Primary Outcome Measures

Name	Time	Method
Fibrous cap thickness by OCT	12 months

Secondary Outcome Measures

Name	Time	Method
macrophage number	12 months

Trial Locations

Locations (1)

Wakayama Medical University; 🇯🇵 Wakayama, Japan