Evaluation of Atorvastatin on Atherosclerosis Composition

NCT00576576 | Completed Results DMC

• 3 other identifiers: IRB00000701GA2580TTEmory #07052168
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of Atorvastatin on the coronary atherosclerosis plaque morphology.

Conditions

Atherosclerosis

Keywords

Atherosclerosis, vulnerable plaque, IVUS, shear stress

Outcome Measures

Primary Outcomes (1)

• Change in Necrotic Core Volume

  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).

  6 months

Secondary Outcomes (2)

• Change in Atheroma Volume

  6 months

• Change in Fibrous Plaque Volume

  6 months

Study Arms (1)

A

EXPERIMENTAL

All patients in this arm are given atorvastatin therapy.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Atorvastatin 80 mg a day

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• Pfizer: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• Kawasaki M, Sano K, Okubo M, Yokoyama H, Ito Y, Murata I, Tsuchiya K, Minatoguchi S, Zhou X, Fujita H, Fujiwara H. Volumetric quantitative analysis of tissue characteristics of coronary plaques after statin therapy using three-dimensional integrated backscatter intravascular ultrasound. J Am Coll Cardiol. 2005 Jun 21;45(12):1946-53. doi: 10.1016/j.jacc.2004.09.081.

  PMID: 15963391 BACKGROUND

• Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.

  PMID: 21788584 RESULT

• Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Avati Nanjundappa RP, Sawaya FJ, King AR, Oshinski JN, Taylor WR, Quyyumi AA, Giddens DP, Samady H. Coronary Plaque Progression Occurs Distal to Stenoses in Segments with Low Wall Shear Stress: A Prospective Evaluation in Patients with Coronary Artery Disease. Arterioscler Thromb Vasc Biol 2010;30(11);e251.

  RESULT

• Eshtehardi P, McDaniel MC, Dhawan SS, Binongo JN, Krishnan SK, Golub L, Corban MT, Raggi P, Quyyumi AA, Samady H. Effect of intensive atorvastatin therapy on coronary atherosclerosis progression, composition, arterial remodeling, and microvascular function. J Invasive Cardiol. 2012 Oct;24(10):522-9.

  PMID: 23043036 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

No adverse events to report.

Results Point of Contact

• Title: Dr. Habib Samady
• Organization: Emory

hsamady@emory.edu

4047781237

Study Officials

• Habib Samady, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 24, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-11

Locations

US (1)