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Evaluation of Atorvastatin on Atherosclerosis Composition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576576
First Posted: December 19, 2007
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Habib Samady, Emory University
  Purpose
The purpose of this study is to evaluate the effects of Atorvastatin on the coronary atherosclerosis plaque morphology.

Condition Intervention
Atherosclerosis Drug: Atorvastatin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of Atorvastatin on Wall Shear Stress, Atherosclerosis Composition, and Microvascular Function in Patients With Moderate Coronary Disease

Resource links provided by NLM:


Further study details as provided by Habib Samady, Emory University:

Primary Outcome Measures:
  • Change in Necrotic Core Volume [ Time Frame: 6 months ]
    Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).


Secondary Outcome Measures:
  • Change in Atheroma Volume [ Time Frame: 6 months ]
    Change in atheroma volume between baseline and follow-up is reported. This was derived by subtracting the baseline value from the 6-month value.

  • Change in Fibrous Plaque Volume [ Time Frame: 6 months ]
    Change in fibrous plaque volume between baseline and follow-up. This was derived by subtracting the baseline value from the 6-month value.


Enrollment: 27
Study Start Date: July 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
All patients in this arm are given atorvastatin therapy.
Drug: Atorvastatin
Atorvastatin 80 mg a day

Detailed Description:

The primary goal of this project is to evaluate the effect of the cholesterol lowering drug Atorvastatin on the composition and character of coronary atherosclerosis (heart blockages). Atorvastatin is known to reduce cholesterol, reduce cardiac events, and halt the progression of coronary atherosclerosis. However, the reduction in cardiac events is out of proportion to the reductions in the total amount of atherosclerosis. Thus, the drug likely decreases cardiac events by changing the composition of the coronary atherosclerotic plaques. It is likely that the drug causes the "heart blockage" to change from a "vulnerable plaque" to a "stable" plaque. There are several features of "vulnerable plaques" that can be detected in arteries of the heart using intravascular ultrasound. The goal of this project is to examine the effects of atorvastatin on atherosclerosis plaque composition using this intravascular ultrasound in patients undergoing serial cardiac catheterizations. Our hypothesis is that atorvastatin will reduce the number of "vulnerable plaques" and increase the number of "stable plaques" seen by intravascular ultrasound. We plan to enroll a total of 20 patients. The patients will be evaluated by cardiac catheterization with intravascular ultrasound analysis and then be treated with atorvastatin for 6 months. These 20 patients will return to the cardiac catheterization laboratory 6 months later for a repeat catheterization with intravascular ultrasound evaluation.

The secondary goal of this proposal is to evaluate in humans the relationship between coronary atherosclerosis (plaque buildup in the arteries of the heart) and wall shear stress (the force generated against the wall of the artery by the flow of blood). The reason for this sub-study is that there is great interest in understanding the characteristics that cause the progression of coronary atherosclerosis. Local forces such as shear stress may play an important role in the focal progression of "vulnerable" atherosclerotic plaques. Indeed, low shear stress is known to be an important factor in the early formation of atherosclerosis. However, the relationship of low shear stress to development and progression of advanced "rupture prone" ("vulnerable") plaques has not been elucidated. Our hypotheses are: (1) "Vulnerable plaques" are more commonly located at areas of low shear stress(2) "Vulnerable plaques" at areas of low shear stress are more likely to progress over the following 6 months than plaques located in normal shear stress regions.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576576


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Pfizer
Investigators
Principal Investigator: Habib Samady, MD Emory University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Habib Samady, MD, Emory University
ClinicalTrials.gov Identifier: NCT00576576     History of Changes
Other Study ID Numbers: IRB00000701
GA2580TT ( Other Identifier: Other )
Emory #07052168 ( Other Identifier: Other )
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: November 28, 2012
Results First Posted: October 18, 2013
Last Update Posted: December 24, 2013
Last Verified: November 2013

Keywords provided by Habib Samady, Emory University:
Atherosclerosis, vulnerable plaque, IVUS, shear stress

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors