Lovaza Therapy of Peripheral Arterial Disease - Tabular View

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Lovaza Therapy of Peripheral Arterial Disease

This study is currently recruiting participants.

Study NCT00569686. Last updated on June 4, 2008. Information provided by University of Virginia

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Lovaza Therapy of Peripheral Arterial Disease

Official Title ^†

Lovaza Therapy of Peripheral Arterial 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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Peripheral Artery Disease

Intervention ^†

Drug: lovaza
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

September 2007

Completion Date

December 2008

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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: jayne missel, RN CCRC

434-243-7195

jsm3s@virginia.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00569686

Organization ID

13107

Secondary IDs ^††

Study Sponsor ^†

University of Virginia

Collaborators ^††

Reliant Pharmaceuticals

Investigators ^†

Principal Investigator:

Christopher Kramer, MD

University of Virginia Health System

Information Provided By

University of Virginia

Verification Date

June 2008

First Received Date ^†

December 6, 2007

Last Updated Date

June 4, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.