OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease

Phase 3

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Placebo; Drug: OMACOR

• Registration Number: NCT01367145
• Lead Sponsor: Medical University of Vienna

Brief Summary

The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with PAD.

Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.

Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound.

Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-24
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Severity of disease: Rutherford category II or III - moderate to severe Stable intermittent claudication
• Ankle Brachial Index<0.9
• Age ≥18 years
• Adequate PAD therapy according to current AHA guidelines

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Exclusion Criteria

• Current treatment with Omacor or other fish oil products
• Planned vascular intervention
• Known hypersensitivity to the study drug
• Rest pain or ischemic ulcer
• Exercise tolerance limited by factors other than PAD
• Inability to perform treadmill test
• Dual antiplatelet therapy (aspirin and clopidogrel)
• Previous myocardial infarction
• Known liver diseases, except fatty liver
• Known bleeding diathesis
• Women of childbearing potential who do not practice a safe contraception method
• Current participation in another intervention study.
• Previous participation in another study with an intervention within the last 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Omacor	OMACOR	-

Primary Outcome Measures

Name	Time	Method
change from baseline endothelial function to 3 months	baseline, 3 months	measured by flow mediated vasodilation

Secondary Outcome Measures

Name	Time	Method
change from baseline endothelial function to six months	baseline, 6 months (3 months after treatment cessation)
change of inflammatory markers from baseline to one, three and six months	baseline, 1, 3, 6 months
change of pulse wave velocity from baseline to one, three and six months	baseline, 1, 3, 6 months
change of platelet activation from baseline to one, three and six months	baseline, 1, 3, 6 months
liver enzymes changes	baseline, 1,3,6 months
change of walking distance (maximum/pain-free)from baseline to three months and six months	baseline, 3, 6 months
bleeding events	1, 3, 6 months

Trial Locations

Locations (1)

Medical University of Vienna, Department of Internal Medicine II, Division of Angiology; 🇦🇹 Vienna, Austria