Lovaza Therapy of Peripheral Arterial Disease

Study Overview
=================
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.

Official Title
-----------------
Lovaza Therapy of Peripheral Arterial Disease

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Drug: lovaza
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>treatment with lovaza | Drug: lovaza<br>* lovaza 4 gm po daily<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, peripheral artery disease