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

NCT00640744

Last updated date
Study Location
Baylor College of Medicine
Houston, Texas, 77030, United States
Contact
713-798-4128

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atherosclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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AtherosclerosisEffect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions
NCT00640744
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions
Official Title  ICMJE Phase 3 Study of Atorvastatin Effects on Carotid Atherosclerosis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE Drug: Atorvastatin
Atorvastatin 80 mg tablet/day for 3 months
Study Arms  ICMJE 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
Intervention: Drug: Atorvastatin
Publications * Choudhary S, Higgins CL, Chen IY, Reardon M, Lawrie G, Vick GW 3rd, Karmonik C, Via DP, Morrisett JD. Quantitation and localization of matrix metalloproteinases and their inhibitors in human carotid endarterectomy tissues. Arterioscler Thromb Vasc Biol. 2006 Oct;26(10):2351-8. Epub 2006 Aug 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 20, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2010
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640744
Other Study ID Numbers  ICMJE H-18077
HL 063090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joel D. Morrisett, Ph.D., Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Joel D Morrisett, PhDBaylor College of Medicine
Study Director:Addison M Taylor, MD, PhDBaylor College of Medicine
Study Chair:William Insull, MDBaylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP