NCT00700037

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

2.5 years

First QC Date

June 13, 2008

Last Update Submit

October 28, 2014

Conditions

Acute Coronary SyndromeAtherosclerosisDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Fibrous cap thickness by OCT

    12 months

Secondary Outcomes (1)

  • macrophage number

    12 months

Study Arms (2)

1

EXPERIMENTAL

Atorvastatin 20mg

Drug: high-dose atorvastatin

2

ACTIVE COMPARATOR

atorvastatin 5mg

Drug: low-dose atorvastatin

Interventions

high-dose atorvastatinDRUG

20mg/day

Also known as: Lipitor20
1
low-dose atorvastatinDRUG

5mg/day

Also known as: Lipitor5
2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wakayama Medical University

Wakayama, Wakayama, 641-8509, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25456755DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeAtherosclerosisDyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Takashi Akasaka

    Wakayama Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

August 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

JP(1)