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Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307307
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : May 22, 2006
The Dana Foundation
Merck Sharp & Dohme LLC
Kos Pharmaceuticals
Information provided by:
University of Pennsylvania

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Magnetic Resonance Characterization of Carotid Atherosclerotic Plaque in Vivo: Effect of High Density Lipoprotein Elevation on Plaque Morphology
Study Start Date : January 2000
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in MRI estimates of carotid atherosclerosis

Secondary Outcome Measures :
  1. Change in lipoproteins and inflammatory markers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307307

Sponsors and Collaborators
University of Pennsylvania
The Dana Foundation
Merck Sharp & Dohme LLC
Kos Pharmaceuticals
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Principal Investigator: Muredach P Reilly, MB MSCE University of Pennsylvania
Layout table for additonal information Identifier: NCT00307307    
Other Study ID Numbers: CARMA
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: May 22, 2006
Last Verified: March 2006
Keywords provided by University of Pennsylvania:
HDL cholesterol
MR imaging
Additional relevant MeSH terms:
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Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Vitamin B Complex
Physiological Effects of Drugs