Lovaza Therapy of Peripheral Arterial Disease
| Status: | Withdrawn |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 5/9/2018 |
| Start Date: | September 2007 |
| End Date: | February 2010 |
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.
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.
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
We found this trial at
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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