Status:
COMPLETED
Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
The Dana Foundation
Merck Sharp & Dohme LLC
Conditions:
Established Carotid Atherosclerosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The primary objective of this randomized, double blind, placebo controlled pilot study is to determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhibitor - simvastatin) or incr...
Detailed Description
FULL PROTOCOL 1.0 SYNOPSIS The primary objective of this randomized, double blind, placebo controlled pilot study is to determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhi...
Eligibility Criteria
Inclusion
- Age \> 18 and \< 90 years
- Capacity for giving written informed consent
- Carotid stenosis of \> 30% by ultrasound criteria
- LDL cholesterol level of \> 100mg/dl
- Systolic BP \< 170 and diastolic BP \< 100 under resting conditions
- Negative pregnancy test if female of child-bearing potential
Exclusion
- Recent (\< 3 months) history of stroke, transient ischemic attack, myocardial infarction, unstable angina or critical limb ischemia
- Contraindications to MRI (claustrophobia, presence of pacemakers, defibrillators, metal foreign bodies)
- History of side effect/adverse reaction on HMGCoA reductase inhibitor
- Niaspan or niacin
- Poorly controlled diabetes (HbA1c \> 8%)
- History of myositis, liver disease or abnormal LFTs
- Need for combination therapy for the control of severe hyperlipidemia
- Abnormal LFT (\> 2 fold upper limit normal)
- Active infection or malignancy
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00307307
Start Date
January 1 2000
End Date
September 1 2005
Last Update
May 22 2006
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