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

Study Overview
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Brief Summary
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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.

Official Title
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OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Drug: OMACOR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omacor<br> | Drug: OMACOR<br>* 4 capsules OMACOR 1g per day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 4 capsules placebo per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline endothelial function to 3 months | measured by flow mediated vasodilation | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline endothelial function to six months |  | baseline, 6 months (3 months after treatment cessation) | 
| change of walking distance (maximum/pain-free)from baseline to three months and six months |  | baseline, 3, 6 months | 
| 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 | 
| bleeding events |  | 1, 3, 6 months | 
| liver enzymes changes |  | baseline, 1,3,6 months | 
| change of platelet activation from baseline to one, three and six months |  | baseline, 1, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OMEGA-3 polyunsaturated fatty-acids, Peripheral Arterial Disease, Endothelial Function, Inflammation, Platelet Function