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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Drug: OMACOR; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Department of Internal Medicine II, Division of Angiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; 4 capsules placebo per day
ACTIVE_COMPARATOR: Omacor	Drug: OMACOR; 4 capsules OMACOR 1g per day

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Sabine Steiner, Dr., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (ESTIMATE): June 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 24, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Inflammation; Endothelial Function; Peripheral Arterial Disease; Platelet Function; OMEGA-3 polyunsaturated fatty-acids
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: OMACOR II - 2011