Lovaza Therapy of Peripheral Arterial Disease

Peripheral Artery Disease Clinical Trial

Official title:

Lovaza Therapy of Peripheral Arterial Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00569686
• Other study ID #: 13107
• Status: Withdrawn
• Phase: N/A
• Start date: September 2007
• Est. completion date: February 2010

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• lovaza
lovaza 4 gm po daily
• placebo
placebo

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Reliant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved		1 year