NCT01367145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

2.8 years

First QC Date

May 9, 2011

Last Update Submit

August 24, 2014

Conditions

Peripheral Arterial Disease

Keywords

OMEGA-3 polyunsaturated fatty-acidsPeripheral Arterial DiseaseEndothelial FunctionInflammationPlatelet Function

Outcome Measures

Primary Outcomes (1)

  • change from baseline endothelial function to 3 months

    measured by flow mediated vasodilation

    baseline, 3 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Omacor

ACTIVE COMPARATOR
Drug: OMACOR

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OMACORDRUG

4 capsules OMACOR 1g per day

Omacor
PlaceboDRUG

4 capsules placebo per day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseInflammation

Interventions

Omacor

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sabine Steiner, Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 9, 2011

First Posted

June 6, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2013

Study Completion

March 1, 2014

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

AU(1)