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

Condition(s) targeted: Hypercholesteremia; Coronary Artery Disease

Intervention: atorvastatin, Lipitor (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Inc

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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 outcome:

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)

Minimum age: 20 Years. Maximum age: 74 Years. Gender(s): Both.

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

Osaka, Japan

Tokyo, Japan

Last updated: December 5, 2006