Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque

Astellas Pharma Inc0 sites50 target enrollmentDecember 6, 2006

ConditionsHypercholesteremia Coronary Artery Disease

Drugsatorvastatin, Lipitor

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hypercholesteremia
Sponsor: Astellas Pharma Inc
Enrollment: 50
Primary Endpoint: Changes in plaque characteristics as observed by coronary angioscopy
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 6, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

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)