Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions (DCAT)
Recruitment status was Recruiting
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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 |
- Changes in carotid plaque composition as assessed by MRI and histology [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: William Insull, M.D. | 713-798-4128 | winsull@bcm.tmc.edu |
| Contact: Addison Taylor, MD/PhD | 713-798-4721 | ataylor@bcm.tmc.edu |
| 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 | |
| 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 Carotid Artery Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013