N/A
N=27
Evaluation of Atorvastatin on Atherosclerosis Composition
Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00576576 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Change in Necrotic Core Volume — 0.07 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Necrotic Core Volume |
0.07 | — |
| SECONDARY Change in Atheroma Volume |
-4.0 | — |
| SECONDARY Change in Fibrous Plaque Volume |
-3.3 | — |
Summary
The purpose of this study is to evaluate the effects of Atorvastatin on the coronary atherosclerosis plaque morphology.
Eligibility Criteria
Inclusion Criteria
- The patients are eligible if they are undergoing catheterization for stable angina or acute coronary syndromes
- At the time of catheterization the patient has a "moderate coronary" lesion in the proximal 60mm of an epicardial coronary artery
- "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
- Patient must have decision making capacity and consented prior to the catheterization
- Ages: All ages
- Performance Status: all levels
Exclusion Criteria
- Screening Exclusion Criteria:
- Patients with coronary bypass grafts
- Severe valvular heart disease
- Patients presenting with a ST segment elevation myocardial infarction (STEMI)
- Inability to provide informed consent prior to randomization
- Creatinine >1.5
- Patients who are on a statin with an LDL < 130.
- Any patient on a maximum dose of statin (atorvastatin 80mg, simvastatin 80mg, rosuvastatin 20mg, pravastatin 80mg, or fluvastatin 80mg)
- Uncontrolled diabetes requiring intensification of therapy
- Uncontrolled hypertension requiring the addition of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker
- Angiographic Ineligibility Criteria:
- A Left Main lesion greater than 50% stenosis
- The moderate lesion is located beyond 60mm
- Collaterals
- Coronary Anatomy requiring coronary artery bypass grafting (CABG)
Data sourced from ClinicalTrials.gov (NCT00576576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.