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Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions (DCAT)

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. Identifier: NCT00640744
Recruitment Status : Unknown
Verified December 2010 by Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : March 21, 2008
Last Update Posted : December 7, 2010
Information provided by:
Baylor College of Medicine

Brief Summary:
Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Atorvastatin Phase 4

Detailed Description:
Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
Study Start Date : February 2006
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
An untreated carotid plaque will be obtained at the first endarterectomy. Atorvastatin 80mg will be administered for 3 months. The contralateral (treated) plaque will be obtained at the second endarterectomy. Hence, each patient will be his/her own control
Drug: Atorvastatin
Atorvastatin 80 mg tablet/day for 3 months

Primary Outcome Measures :
  1. Changes in carotid plaque composition as assessed by MRI and histology [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Changes content of cells, proteins and genes in carotid plaque [ Time Frame: 3 months ]
  2. Changes in content of selected proteins and their encoding genes in carotid plaques [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women
  • >18 yrs old
  • Expected to have an endarterectomy on each carotid artery
  • No contraindications for atorvastatin
  • Stable cardiovascular health
  • Lipid lowering treatment less than 6 mo duration
  • Diabetic included if diabetes is controlled
  • Patient is not claustrophobic
  • Patient has evaluable carotid plaques.

Exclusion Criteria:

  • Patient has had previous carotid endarterectomy,stenting, or other procedure
  • Unstable cardiovascular status
  • Hypersensitivity to statin therapy
  • Neck anatomy preventing acquiring bilateral evaluable plaques
  • Weight over 285 lbs.

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 identifier (NCT number): NCT00640744

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Contact: William Insull, M.D. 713-798-4128
Contact: Addison Taylor, MD/PhD 713-798-4721

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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Joel D Morrisett, PhD    713-798-4164   
Contact: Addison Taylor, MD/PhD    713-798-4721   
Principal Investigator: Joel D Morrisett, PhD         
Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: Joel D Morrisett, PhD Baylor College of Medicine
Study Director: Addison M Taylor, MD, PhD Baylor College of Medicine
Study Chair: William Insull, MD Baylor College of Medicine
Additional Information:
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Responsible Party: Joel D. Morrisett, Ph.D., Baylor College of Medicine Identifier: NCT00640744    
Other Study ID Numbers: H-18077
HL 063090
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010
Keywords provided by Baylor College of Medicine:
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors