Lovaza Therapy of Peripheral Arterial Disease

Not Applicable

Withdrawn

• Conditions: Peripheral Artery Disease
• Interventions: Drug: placebo; Drug: lovaza

• Registration Number: NCT00569686
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-07
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	lovaza	treatment with lovaza

Primary Outcome Measures

Name	Time	Method
treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce or prevent progression of atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year as compared to placebo.	one year

Secondary Outcome Measures

Name	Time	Method
show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved	1 year

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States