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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014