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Change in Plaque Characteristics With Atorvastatin (EASY-FIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shigeho Takarada, Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00700037
First received: June 13, 2008
Last updated: October 28, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • macrophage number [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shigeho Takarada, MD, PhD, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00700037     History of Changes
Other Study ID Numbers: wakayamamu08-001
Study First Received: June 13, 2008
Last Updated: October 28, 2014
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Arteriosclerosis
Atherosclerosis
Dyslipidemias
Angina Pectoris
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014