Lovaza Therapy of Peripheral Arterial Disease

NCT00569686 | Withdrawn

• 1 other identifier: 13107
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

PAD; peripheral artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

treatment with lovaza

Drug: lovaza

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

lovaza DRUG

lovaza 4 gm po daily

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Virginia: lead
• Reliant Pharmaceuticals: collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Omacor

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christopher Kramer, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)