Lovaza Therapy of Peripheral Arterial Disease

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569686

Enrollment

Registered

2007-12-07

Start date

2007-09-30

Completion date

2010-02-28

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

PAD, peripheral artery disease

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.

Interventions

DRUGlovaza

lovaza 4 gm po daily

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026