Lovaza Therapy of Peripheral Arterial Disease

This study has been withdrawn prior to enrollment.
(No subject meeting criteria)
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00569686
First received: December 6, 2007
Last updated: March 3, 2010
Last verified: March 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Lovaza Therapy of Peripheral Arterial Disease

Resource links provided by NLM:


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: February 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
treatment with lovaza
Drug: lovaza
lovaza 4 gm po daily
Placebo Comparator: 2 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
  • Patients with iron storage disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569686

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Reliant Pharmaceuticals
Investigators
Principal Investigator: Christopher Kramer, MD University of Virginia Health System
  More Information

No publications provided

Responsible Party: Dr Christopher Kramer, University of Virginia Health System
ClinicalTrials.gov Identifier: NCT00569686     History of Changes
Other Study ID Numbers: 13107
Study First Received: December 6, 2007
Last Updated: March 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
PAD
peripheral artery disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014