Change in Plaque Characteristics With Atorvastatin | NCT00700037

Studies
Change in Plaque Characteristics With Atorvastatin

NCT00700037

Sponsor

Wakayama Medical University

Status

Completed

Last Update Posted

Oct 29, 2014Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Acute Coronary Syndrome
Atherosclerosis
Dyslipidemia

Interventions

high-dose atorvastatin
low-dose atorvastatin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2014

Last Update Posted Date

Oct 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Atorvastatin 20mg	Drug: high-dose atorvastatin
2	Active Comparator	atorvastatin 5mg	Drug: low-dose atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high-dose atorvastatin	Drug	20mg/day	1	Lipitor20

Measure	Description	Time Frame
Fibrous cap thickness by OCT		12 months

Measure	Description	Time Frame
macrophage number		12 months

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Takashi Akasaka	Wakayama Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wakayama Medical University		Wakayama	Wakayama	641-8509	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25456755	Derived	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.

ID	Term
D054058	Acute Coronary Syndrome
D050197	Atherosclerosis
D050171	Dyslipidemias

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds