Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.

This study has been completed.
The Dana Foundation
Merck Sharp & Dohme Corp.
Kos Pharmaceuticals
Information provided by:
University of Pennsylvania Identifier:
First received: March 24, 2006
Last updated: May 18, 2006
Last verified: March 2006

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 increasing HDL cholesterol (Niaspan) will induce regression of carotid atherosclerotic plaque in vivo using MRI imaging techniques. MR plaque morphology at baseline will be compared to that after 6 and 12 months of therapy and changes in MR characteristics will be compared to changes in lipoprotein parameters and urinary isoprostanes. The effect of moderate LDL reduction, aggressive LDL reduction and the combination of aggressive LDL reduction and HDL elevation on MRI plaque characteristics will be compared by randomly assigning subjects (n=69) with carotid disease (>30% stenosis by ultrasound criteria) to one of three treatment arms;

  1. Simvastatin 20 mg daily and placebo Niaspan (n=23)
  2. Simvastatin 80 mg daily and placebo Niaspan (n=23)
  3. Simvastatin 20 mg daily and active Niaspan (n=23) Treatment group 2 and 3 will have roughly equivalent LDL lowering because of the synergistic LDL lowering effect of the combination of simvastatin and Niaspan.

Condition Intervention Phase
Established Carotid Atherosclerosis
Drug: Niacin/simvastatin compared to simvastatin alone at 2 doses
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Magnetic Resonance Characterization of Carotid Atherosclerotic Plaque in Vivo: Effect of High Density Lipoprotein Elevation on Plaque Morphology

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in MRI estimates of carotid atherosclerosis

Secondary Outcome Measures:
  • Change in lipoproteins and inflammatory markers

Estimated Enrollment: 69
Study Start Date: January 2000
Estimated Study Completion Date: September 2005
  Show Detailed Description


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
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Please refer to this study by its identifier: NCT00307307

Sponsors and Collaborators
University of Pennsylvania
The Dana Foundation
Merck Sharp & Dohme Corp.
Kos Pharmaceuticals
Principal Investigator: Muredach P Reilly, MB MSCE University of Pennsylvania
  More Information Identifier: NCT00307307     History of Changes
Other Study ID Numbers: CARMA 
Study First Received: March 24, 2006
Last Updated: May 18, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
HDL cholesterol
MR imaging

Additional relevant MeSH terms:
Carotid Artery Diseases
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2016