Overview

Evaluation of Atorvastatin on Atherosclerosis Composition

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effects of Atorvastatin on the coronary atherosclerosis plaque morphology.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Collaborator:
Pfizer
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
Inclusion Criteria:

1. The patients are eligible if they are undergoing catheterization for stable angina or
acute coronary syndromes

2. At the time of catheterization the patient has a "moderate coronary" lesion in the
proximal 60mm of an epicardial coronary artery

3. "Moderate lesion" is defined as a lesion deemed significant enough to warrant further
evaluation using coronary flow reserve (CFR) and fractional flow reserve (FFR) by the
treating physician

4. Patient must have decision making capacity and consented prior to the catheterization

5. Ages: All ages

6. Performance Status: all levels

Exclusion Criteria:

1. Screening Exclusion Criteria:

1. Patients with coronary bypass grafts

2. Severe valvular heart disease

3. Patients presenting with a ST segment elevation myocardial infarction (STEMI)

4. Inability to provide informed consent prior to randomization

5. Creatinine >1.5

6. Patients who are on a statin with an LDL < 130.

7. Any patient on a maximum dose of statin (atorvastatin 80mg, simvastatin 80mg,
rosuvastatin 20mg, pravastatin 80mg, or fluvastatin 80mg)

8. Uncontrolled diabetes requiring intensification of therapy

9. Uncontrolled hypertension requiring the addition of angiotensin-converting enzyme
inhibitor or angiotensin receptor blocker

2. Angiographic Ineligibility Criteria:

1. A Left Main lesion greater than 50% stenosis

2. The moderate lesion is located beyond 60mm

3. Collaterals

4. Coronary Anatomy requiring coronary artery bypass grafting (CABG)