Recruiting

Atorvastatin

Sponsor:

Baylor College of Medicine

Code:

NCT00640744

Conditions

Atherosclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Atorvastatin

Study Details

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.

Conditions

Atherosclerosis

Study ID

NCT00640744

Start date

Feb, 2006

Status verified date

Dec, 2010

Completion date

Feb, 2010

Anticipated

Primary completion date

Nov, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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

Interventions

Atorvastatin

Atorvastatin 80 mg tablet/day for 3 months

Primary outcome measure

  • Changes in carotid plaque composition as assessed by MRI and histology [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

William Insull, M.D.

713-798-4128winsull@bcm.tmc.edu

Addison Taylor, MD/PhD

713-798-4721ataylor@bcm.tmc.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Joel D Morrisett, PhD

713-798-4164morriset@bcm.tmc.edu

Addison Taylor, MD/PhD

713-798-4721ataylor@bcm.tmc.edu

Principal Investigator:

Joel D Morrisett, PhD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Dec 7, 2010

Last verified

Dec, 2010

Keywords

  • Atherogenesis
  • Atheroma
  • Arteriosclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2010-12-07.