NCT00408382

Brief Summary

To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
Last Updated

November 17, 2011

Status Verified

December 1, 2006

First QC Date

December 5, 2006

Last Update Submit

November 15, 2011

Conditions

HypercholesteremiaCoronary Artery Disease

Keywords

LipitoratorvastatinHypercholesteremiayellow coronary plaque

Outcome Measures

Primary Outcomes (3)

  • Changes in plaque characteristics as observed by coronary angioscopy

  • (the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)

  • Changes in the volume and the echogenicity as observed by intravascular ultrasound

Secondary Outcomes (2)

  • Rate of change in serum lipid level

  • Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)

Interventions

atorvastatin, LipitorDRUG

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypercholesteremia
  • The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

You may not qualify if:

  • Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
  • Acute cardiac infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • Hirayama A, Saito S, Ueda Y, Takayama T, Honye J, Komatsu S, Yamaguchi O, Li Y, Yajima J, Nanto S, Takazawa K, Kodama K. Qualitative and quantitative changes in coronary plaque associated with atorvastatin therapy. Circ J. 2009 Apr;73(4):718-25. doi: 10.1253/circj.cj-08-0755. Epub 2009 Feb 18.

    PMID: 19225206BACKGROUND

MeSH Terms

Conditions

HypercholesterolemiaCoronary Artery Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 6, 2006

Last Updated

November 17, 2011

Record last verified: 2006-12

Locations

JP(2)