Change in Plaque Characteristics With Atorvastatin

Acute Coronary Syndrome Clinical Trial

— EASY-FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700037
• Other study ID #: wakayamamu08-001
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2008
• Last updated: October 28, 2014
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: October 2014
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• high-dose atorvastatin
20mg/day
• low-dose atorvastatin
5mg/day

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrous cap thickness by OCT		12 months	No
Secondary	macrophage number		12 months	No