Study Stopped
The study was terminated on June 22, 2007 for inability to enroll patients within an appropriate timeframe. There were no efficacy/safety concerns.
Evaluation of Atorvastatin Treatment on Carotid Plaque.
A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool
1 other identifier
interventional
160
1 country
1
Brief Summary
The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 cardiovascular-diseases
Started Jan 2007
Shorter than P25 for phase_3 cardiovascular-diseases
1 active site
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
First Submitted
Initial submission to the registry
June 20, 2006
CompletedFirst Posted
Study publicly available on registry
June 23, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFebruary 18, 2021
February 1, 2021
June 20, 2006
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
Comparison of effect of atorvastatin 80mg versus 10mg
Secondary Outcomes (3)
Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.
Correlation of biomarkers to carotid changes.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.
You may not qualify if:
- Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
- Subjects currently on high dose statin, and
- Subjects with contraindications for MRI or statin therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2006
First Posted
June 23, 2006
Study Start
January 1, 2007
Study Completion
August 1, 2007
Last Updated
February 18, 2021
Record last verified: 2021-02