Lovaza Therapy of Peripheral Arterial Disease

• Status: Withdrawn
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: Reliant Pharmaceuticals

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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