Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.

NCT00307307 | Completed Phase 4

• 1 other identifier: CARMA
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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. 1.Simvastatin 20 mg daily and placebo Niaspan (n=23)
2. 2.Simvastatin 80 mg daily and placebo Niaspan (n=23)
3. 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.

Conditions

Established Carotid Atherosclerosis

Keywords

atherosclerosis; HDL cholesterol; niacin; MR imaging

Outcome Measures

Primary Outcomes (1)

• Change in MRI estimates of carotid atherosclerosis

Secondary Outcomes (1)

• Change in lipoproteins and inflammatory markers

Interventions

Niacin/simvastatin compared to simvastatin alone at 2 doses DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• The Dana Foundation: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Kos Pharmaceuticals: collaborator

MeSH Terms

Conditions

Atherosclerosis

Interventions

Niacin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Muredach P Reilly, MB MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 27, 2006
• Study Start: January 1, 2000
• Study Completion: September 1, 2005
• Last Updated: May 22, 2006

Record last verified: 2006-03