Effect of Short Term Atorvastatin Treatment,80mg/Day on E... | NCT00640744

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

NCT00640744

Sponsor

Baylor College of Medicine

Status

Unknown status

Last Update Posted

Dec 7, 2010Estimated

Enrollment

12Estimated

Phase

Phase 4

Conditions

Atherosclerosis

Interventions

Atorvastatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HL 063090

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Nov 2009Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Mar 20, 2008

First Posted Date

Mar 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2010

Last Update Posted Date

Dec 7, 2010Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	Atorvastatin 80 mg tablet/day for 3 months	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in carotid plaque composition as assessed by MRI and histology		3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
William Insull, M.D.	Contact	713-798-4128		winsull@bcm.tmc.edu
Addison Taylor, MD/PhD	Contact	713-798-4721		ataylor@bcm.tmc.edu

Overall Officials

Name	Affiliation	Role
Joel D Morrisett, PhD	Baylor College of Medicine	Principal Investigator
Addison M Taylor, MD, PhD	Baylor College of Medicine	Study Director
William Insull, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor College of Medicine	Recruiting	Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16888239	Background	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.

Type	Date	Date Unknown
Release	Mar 8, 2024
Reset	Apr 4, 2024

ID	Term
D050197	Atherosclerosis
D058226	Plaque, Atherosclerotic
D001161	Arteriosclerosis

ID	Term
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D020763	Pathological Conditions, Anatomical

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds