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

Phase 4

Completed

• Conditions: Hypercholesteremia; Coronary Artery Disease

• Registration Number: NCT00408382
• Lead Sponsor: Astellas Pharma Inc

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-12
• Study First Submitted: 2006-12-05
• Study First Submitted QC: 2006-12-05
• Study First Posted: 2006-12-06
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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)