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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00640744
First received: January 2, 2008
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Atherosclerosis
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Changes in carotid plaque composition as assessed by MRI and histology [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes content of cells, proteins and genes in carotid plaque [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in content of selected proteins and their encoding genes in carotid plaques [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: February 2006
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640744

Contacts
Contact: William Insull, M.D. 713-798-4128 winsull@bcm.tmc.edu
Contact: Addison Taylor, MD/PhD 713-798-4721 ataylor@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Joel D Morrisett, PhD    713-798-4164    morriset@bcm.tmc.edu   
Contact: Addison Taylor, MD/PhD    713-798-4721    ataylor@bcm.tmc.edu   
Principal Investigator: Joel D Morrisett, PhD         
Sponsors and Collaborators
Baylor College of Medicine
Pfizer
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Joel D. Morrisett, Ph.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00640744     History of Changes
Other Study ID Numbers: H-18077, HL 063090
Study First Received: January 2, 2008
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Atherogenesis
Atheroma
Arteriosclerosis

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

ClinicalTrials.gov processed this record on October 19, 2014