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Clinical Trials/NCT01367145
NCT01367145CompletedPhase 3

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

Medical University of Vienna1 site in 1 country71 target enrollmentStarted: January 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
71
Locations
1
Primary Endpoint
change from baseline endothelial function to 3 months
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Omacor

Active Comparator

Intervention: OMACOR (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

change from baseline endothelial function to 3 months

Time Frame: baseline, 3 months

measured by flow mediated vasodilation

Secondary Outcomes

  • bleeding events(1, 3, 6 months)
  • change from baseline endothelial function to six months(baseline, 6 months (3 months after treatment cessation))
  • 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)
  • change of platelet activation from baseline to one, three and six months(baseline, 1, 3, 6 months)
  • liver enzymes changes(baseline, 1,3,6 months)
  • change of walking distance (maximum/pain-free)from baseline to three months and six months(baseline, 3, 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sabine Steiner

Prof.

Medical University of Vienna

Study Sites (1)

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