Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.

This study has been completed.
Sponsor:
Collaborators:
The Dana Foundation
Merck Sharp & Dohme Corp.
Kos Pharmaceuticals
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00307307
First received: March 24, 2006
Last updated: May 18, 2006
Last verified: March 2006
  Purpose

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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307307

Sponsors and Collaborators
University of Pennsylvania
The Dana Foundation
Merck Sharp & Dohme Corp.
Kos Pharmaceuticals
Investigators
Principal Investigator: Muredach P Reilly, MB MSCE University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov 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:
atherosclerosis
HDL cholesterol
niacin
MR imaging

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Niacin
Simvastatin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014