Ignite Creation Date:
2024-05-05 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00569686
Status:
WITHDRAWN
Last Update Posted:
2018-05-07
First Post:
2007-12-06
Brief Title:
Lovaza Therapy of Peripheral Arterial Disease
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Lovaza Therapy of Peripheral Arterial Disease
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No subject meeting criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sixty patients with mild-to-moderate PAD ABI 04-09 and hypertriglyceridemia 200 mgdl 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None