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OpenTrials
Completed

NCT Number: NCT00700037

Change in Plaque Characteristics With Atorvastatin

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.

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemia Dyslipidemias Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wakayama Medical University

Wakayama, 641-8509, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high-dose atorvastatin

Drug

20mg/day

Other names: Lipitor20

low-dose atorvastatin

Drug

5mg/day

Other names: Lipitor5

Primary outcomes

  1. Fibrous cap thickness by OCT

    Time frame: 12 months

Secondary outcomes

  1. macrophage number

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

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

Acronym: EASY-FIT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2008
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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