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Change in Plaque Characteristics With Atorvastatin (EASY-FIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700037
First Posted: June 18, 2008
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shigeho Takarada, Wakayama Medical University
  Purpose
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 Atherosclerosis Dyslipidemia Drug: high-dose atorvastatin Drug: low-dose atorvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Shigeho Takarada, 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
20mg/day
Other Name: Lipitor20
Active Comparator: 2
atorvastatin 5mg
Drug: low-dose atorvastatin
5mg/day
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700037


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shigeho Takarada, MD, PhD, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00700037     History of Changes
Other Study ID Numbers: wakayamamu08-001
First Submitted: June 13, 2008
First Posted: June 18, 2008
Last Update Posted: October 29, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Atherosclerosis
Acute Coronary Syndrome
Dyslipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors