Lovaza Therapy of Peripheral Arterial Disease

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Peripheral Artery Disease

In brief

Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (\>200 mg/dl) already treated with statins will be imaged at baseline and randomized to Lovaza and placebo for 12 months. MR imaging will be repeated at the end of the 12-month period. We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year compared to placebo. Secondary aims will be to show improved plaque characteristics (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance with Lovaza compared to matching placebo.

Key facts

Study ID

NCT00569686

Run by

University of Virginia

People needed

0

Starts

2007-09-01

Expected to finish

2010-02-01

Last updated by the study team

2018-05-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, any ethnicity, ages 55-75
• Mild to moderate PAD (ankle brachial index (ABI) of 0.4-0.9 in either or both limbs)
• Symptomatic intermittent claudication in either or both limbs
• Hyperlipidemia treated with HMG-CoA reductase inhibition with persistent hypertriglyceridemia (triglycerides>200).

You may not qualify if…

• Patients with critical limb ischemia
• Moderate to severe chronic kidney disease (requiring hemodialysis or glomerular filtration rate (GFR) < 45 ml/min)
• Contraindication to MRI (pacemakers, defibrillators, intraocular metal, certain intracerebral aneurysm clips, etc.)
• Claustrophobia
• Known allergy to gadolinium chelates
• Patients with iron storage disease

Where it is running

• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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