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

This study has been completed.
Information provided by (Responsible Party):
Sabine Steiner, Medical University of Vienna Identifier:
First received: May 9, 2011
Last updated: August 24, 2014
Last verified: August 2014

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 Intervention Phase
Peripheral Arterial Disease Drug: OMACOR Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

Further study details as provided by Sabine Steiner, Medical University of Vienna:

Primary Outcome Measures:
  • change from baseline endothelial function to 3 months [ Time Frame: baseline, 3 months ]
    measured by flow mediated vasodilation

Secondary Outcome Measures:
  • change from baseline endothelial function to six months [ Time Frame: baseline, 6 months (3 months after treatment cessation) ]
  • change of walking distance (maximum/pain-free)from baseline to three months and six months [ Time Frame: baseline, 3, 6 months ]
  • change of inflammatory markers from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
  • change of pulse wave velocity from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
  • bleeding events [ Time Frame: 1, 3, 6 months ]
  • liver enzymes changes [ Time Frame: baseline, 1,3,6 months ]
  • change of platelet activation from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]

Enrollment: 71
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omacor Drug: OMACOR
4 capsules OMACOR 1g per day
Placebo Comparator: Placebo Drug: Placebo
4 capsules placebo per day


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT01367145

Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Sabine Steiner, Dr. Medical University of Vienna
  More Information

Responsible Party: Sabine Steiner, Prof., Medical University of Vienna Identifier: NCT01367145     History of Changes
Other Study ID Numbers: OMACOR II - 2011
Study First Received: May 9, 2011
Last Updated: August 24, 2014

Keywords provided by Sabine Steiner, Medical University of Vienna:
OMEGA-3 polyunsaturated fatty-acids
Peripheral Arterial Disease
Endothelial Function
Platelet Function

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017