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Change in Plaque Characteristics With Atorvastatin (EASY-FIT)

This study has been completed.
Information provided by (Responsible Party):
Shigeho Takarada, Wakayama Medical University Identifier:
First received: June 13, 2008
Last updated: October 28, 2014
Last verified: October 2014
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.

Condition Intervention Phase
Acute Coronary Syndrome
Drug: high-dose atorvastatin
Drug: low-dose atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography

Resource links provided by NLM:

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Fibrous cap thickness by OCT [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • macrophage number [ Time Frame: 12 months ]

Enrollment: 70
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atorvastatin 20mg
Drug: high-dose atorvastatin
Other Name: Lipitor20
Active Comparator: 2
atorvastatin 5mg
Drug: low-dose atorvastatin
Other Name: Lipitor5

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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00700037

Wakayama Medical University
Wakayama, Japan, 641-8509
Sponsors and Collaborators
Wakayama Medical University
Principal Investigator: Takashi Akasaka Wakayama Medical University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shigeho Takarada, MD, PhD, Wakayama Medical University Identifier: NCT00700037     History of Changes
Other Study ID Numbers: wakayamamu08-001
Study First Received: June 13, 2008
Last Updated: October 28, 2014

Additional relevant MeSH terms:
Acute Coronary Syndrome
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017