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Completed

NCT Number: NCT01367145

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna, Department of Internal Medicine II, Division of Angiology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMACOR

Drug

4 capsules OMACOR 1g per day

Placebo

Drug

4 capsules placebo per day

Primary outcomes

  1. change from baseline endothelial function to 3 months

    Time frame: baseline, 3 months

    measured by flow mediated vasodilation

Secondary outcomes

  1. change from baseline endothelial function to six months

    Time frame: baseline, 6 months (3 months after treatment cessation)

  2. change of walking distance (maximum/pain-free)from baseline to three months and six months

    Time frame: baseline, 3, 6 months

  3. change of inflammatory markers from baseline to one, three and six months

    Time frame: baseline, 1, 3, 6 months

  4. change of pulse wave velocity from baseline to one, three and six months

    Time frame: baseline, 1, 3, 6 months

  5. bleeding events

    Time frame: 1, 3, 6 months

  6. liver enzymes changes

    Time frame: baseline, 1,3,6 months

  7. change of platelet activation from baseline to one, three and six months

    Time frame: baseline, 1, 3, 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 6, 2011
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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