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Change in Plaque Characteristics With Atorvastatin (EASY-FIT)

Primary Purpose

Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
high-dose atorvastatin
low-dose atorvastatin
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wakayama Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Atorvastatin 20mg

atorvastatin 5mg

Outcomes

Primary Outcome Measures

Fibrous cap thickness by OCT

Secondary Outcome Measures

macrophage number

Full Information

First Posted
June 13, 2008
Last Updated
October 28, 2014
Sponsor
Wakayama Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00700037
Brief Title
Change in Plaque Characteristics With Atorvastatin
Acronym
EASY-FIT
Official Title
Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wakayama Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Atorvastatin 20mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
atorvastatin 5mg
Intervention Type
Drug
Intervention Name(s)
high-dose atorvastatin
Other Intervention Name(s)
Lipitor20
Intervention Description
20mg/day
Intervention Type
Drug
Intervention Name(s)
low-dose atorvastatin
Other Intervention Name(s)
Lipitor5
Intervention Description
5mg/day
Primary Outcome Measure Information:
Title
Fibrous cap thickness by OCT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
macrophage number
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Akasaka
Organizational Affiliation
Wakayama Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wakayama Medical University
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25456755
Citation
Komukai K, Kubo T, Kitabata H, Matsuo Y, Ozaki Y, Takarada S, Okumoto Y, Shiono Y, Orii M, Shimamura K, Ueno S, Yamano T, Tanimoto T, Ino Y, Yamaguchi T, Kumiko H, Tanaka A, Imanishi T, Akagi H, Akasaka T. Effect of atorvastatin therapy on fibrous cap thickness in coronary atherosclerotic plaque as assessed by optical coherence tomography: the EASY-FIT study. J Am Coll Cardiol. 2014 Dec 2;64(21):2207-17. doi: 10.1016/j.jacc.2014.08.045. Epub 2014 Nov 24.
Results Reference
derived

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Change in Plaque Characteristics With Atorvastatin

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