Change in Plaque Characteristics With Atorvastatin

NCT ID: NCT00700037

Last Updated: 2014-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome Atherosclerosis Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Atorvastatin 20mg

Group Type EXPERIMENTAL

high-dose atorvastatin

Intervention Type DRUG

20mg/day

2

atorvastatin 5mg

Group Type ACTIVE_COMPARATOR

low-dose atorvastatin

Intervention Type DRUG

5mg/day

Interventions

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high-dose atorvastatin

20mg/day

Intervention Type DRUG

low-dose atorvastatin

5mg/day

Intervention Type DRUG

Other Intervention Names

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Lipitor20 Lipitor5

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wakayama Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shigeho Takarada

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Takashi Akasaka

Role: PRINCIPAL_INVESTIGATOR

Wakayama Medical University

Locations

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Wakayama Medical University

Wakayama, Wakayama, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 25456755 (View on PubMed)

Other Identifiers

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wakayamamu08-001

Identifier Type: -

Identifier Source: org_study_id

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