Clinical trial NCT01367145: OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
Official title: OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Arterial Disease
Keywords: OMEGA-3 polyunsaturated fatty-acids
Peripheral Arterial Disease
Endothelial Function
Inflammation
Platelet Function
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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
* 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

Primary outcomes:
measure: change from baseline endothelial function to 3 months
timeFrame: baseline, 3 months
Secondary outcomes:
measure: change from baseline endothelial function to six months
timeFrame: baseline, 6 months (3 months after treatment cessation)
measure: change of walking distance (maximum/pain-free)from baseline to three months and six months
timeFrame: baseline, 3, 6 months
measure: change of inflammatory markers from baseline to one, three and six months
timeFrame: baseline, 1, 3, 6 months
measure: change of pulse wave velocity from baseline to one, three and six months
timeFrame: baseline, 1, 3, 6 months
measure: bleeding events
timeFrame: 1, 3, 6 months
measure: liver enzymes changes
timeFrame: baseline, 1,3,6 months
measure: change of platelet activation from baseline to one, three and six months
timeFrame: baseline, 1, 3, 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
Study officials:
affiliation: Medical University of Vienna
name: Sabine Steiner, Dr.
role: PRINCIPAL_INVESTIGATOR
References: