NCT00640744

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

3.8 years

First QC Date

January 2, 2008

Last Update Submit

December 2, 2010

Conditions

Atherosclerosis

Keywords

AtherogenesisAtheromaArteriosclerosis

Outcome Measures

Primary Outcomes (1)

  • Changes in carotid plaque composition as assessed by MRI and histology

    3 months

Secondary Outcomes (2)

  • Changes content of cells, proteins and genes in carotid plaque

    3 months

  • Changes in content of selected proteins and their encoding genes in carotid plaques

    3 months

Study Arms (1)

A

OTHER

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

Interventions

AtorvastatinDRUG

Atorvastatin 80 mg tablet/day for 3 months

A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • 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. doi: 10.1161/01.ATV.0000239461.87113.0b. Epub 2006 Aug 3.

    PMID: 16888239BACKGROUND

MeSH Terms

Conditions

AtherosclerosisPlaque, AtheroscleroticArteriosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Joel D Morrisett, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Addison M Taylor, MD, PhD

    Baylor College of Medicine

    STUDY DIRECTOR

  • William Insull, MD

    Baylor College of Medicine

    STUDY CHAIR

Central Study Contacts

William Insull, M.D.

CONTACT

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

Addison Taylor, MD/PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

March 21, 2008

Study Start

February 1, 2006

Primary Completion

November 1, 2009

Study Completion

February 1, 2010

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

US(1)