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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367145
First Posted: June 6, 2011
Last Update Posted: August 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sabine Steiner, Medical University of Vienna
  Purpose

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
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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367145


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

Responsible Party: Sabine Steiner, Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01367145     History of Changes
Other Study ID Numbers: OMACOR II - 2011
First Submitted: May 9, 2011
First Posted: June 6, 2011
Last Update Posted: August 26, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases