Lovaza Therapy of Peripheral Arterial Disease - Full Text View

Purpose

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.

Condition	Intervention
Peripheral Artery Disease	Drug: lovaza Drug: placebo

MedlinePlus related topics:

Exercise and Physical Fitness Triglycerides

ChemIDplus related topics:

Omacor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Official Title:	Lovaza Therapy of Peripheral Arterial Disease

Further study details as provided by University of Virginia:

Primary Outcome Measures:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Active Comparator treatment with lovaza	Drug: lovaza lovaza 4 gm po daily
2: Placebo Comparator	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569686

Contacts


Contact: jayne missel, RN CCRC	434-243-7195	jsm3s@virginia.edu

Locations


United States, Virginia
	University of Virginia Health System	Recruiting
	charlottesville, Virginia, United States, 22908
	Sub-Investigator: anderson justin, MD
	Sub-Investigator: jehle alexander, MD
	Sub-Investigator: patrick norton, MD
	Sub-Investigator: klaus hagspiel, MD
	Sub-Investigator: amit patel, MD

Sponsors and Collaborators

University of Virginia

Reliant Pharmaceuticals

Investigators


Principal Investigator:	Christopher Kramer, MD	University of Virginia Health System

More Information

Responsible Party:	University of Virginia Health System ( Dr Christopher Kramer )
Study ID Numbers:	13107
First Received:	December 6, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00569686
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Virginia:

PAD

peripheral artery disease

Study placed in the following topic categories:

Peripheral Vascular Diseases

Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	University of Virginia Reliant Pharmaceuticals
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00569686