Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | February 2006 |
| End Date: | February 2010 |
| Contact: | William Insull, M.D. |
| Email: | winsull@bcm.tmc.edu |
| Phone: | 713-798-4128 |
Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
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.
(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.
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.
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.
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.
We found this trial at
1
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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