OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL
Overview
- Phase
- Phase 3
- Intervention
- OMACOR
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Medical University of Vienna
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- change from baseline endothelial function to 3 months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Sabine Steiner
Prof.
Medical University of Vienna
Eligibility 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
Arms & Interventions
Omacor
Intervention: OMACOR
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
change from baseline endothelial function to 3 months
Time Frame: baseline, 3 months
measured by flow mediated vasodilation
Secondary Outcomes
- bleeding events(1, 3, 6 months)
- 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)