Peripheral Arterial Disease
Conditions
Keywords
OMEGA-3 polyunsaturated fatty-acids, Peripheral Arterial Disease, Endothelial Function, Inflammation, Platelet Function
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.
Interventions
DRUGOMACOR
4 capsules OMACOR 1g per day
DRUGPlacebo
4 capsules placebo per day
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline endothelial function to 3 months | baseline, 3 months | measured by flow mediated vasodilation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| change from baseline endothelial function to six months | baseline, 6 months (3 months after treatment cessation) |
| 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 |
| bleeding events | 1, 3, 6 months |
Countries
Austria
Outcome results
None listed