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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01367145

Collaborator

(none)

Enrollment

Location

Arms

37.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Drug: OMACOR Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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 Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Omacor	Drug: OMACOR 4 capsules OMACOR 1g per day
Placebo Comparator: Placebo	Drug: Placebo 4 capsules placebo per day

Arm

Intervention/Treatment

Active Comparator: Omacor

Drug: OMACOR

4 capsules OMACOR 1g per day

Placebo Comparator: Placebo

Drug: Placebo

4 capsules placebo per day

Outcome Measures

Primary Outcome Measures

change from baseline endothelial function to 3 months [baseline, 3 months]
measured by flow mediated vasodilation

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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