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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna

Criteria

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

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