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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omacor | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMACOR | Drug | 4 capsules OMACOR 1g per day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline endothelial function to 3 months | measured by flow mediated vasodilation | baseline, 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Steiner, Dr. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Internal Medicine II, Division of Angiology | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Drug |
4 capsules placebo per day |
|
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |