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

This study is currently recruiting participants.
Verified June 2011 by Medical University of Vienna
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01367145
First received: May 9, 2011
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • change from baseline endothelial function to 3 months [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • change of walking distance (maximum/pain-free)from baseline to three months and six months [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • change of inflammatory markers from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • change of pulse wave velocity from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • bleeding events [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: Yes ]
  • liver enzymes changes [ Time Frame: baseline, 1,3,6 months ] [ Designated as safety issue: Yes ]
  • change of platelet activation from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367145

Contacts
Contact: Alexandra Hammer, Dr. +43 1 40400 ext 4670 alexandra.hammer@meduniwien.ac.at
Contact: Sabine Steiner, Dr. +43 1 40400 ext 4670 sabine.steiner-boeker@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Internal Medicine II, Division of Angiology Recruiting
Vienna, Austria, 1090
Contact: Sabine Steiner, Dr.     +43 1 40400 ext 4670     sabine.steiner-boeker@meduniwien.ac.at    
Contact: Alexandra Hammer, Dr.     +43 1 40 400 ext 4670     alexandra.hammer@meduniwien.ac.at    
Principal Investigator: Sabine Steiner, Dr.            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sabine Steiner, Dr. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Sabine Steiner, Medical University of Vienna, Department of Internal Medicin II, Division of Angiology
ClinicalTrials.gov Identifier: NCT01367145     History of Changes
Other Study ID Numbers: OMACOR II - 2011
Study First Received: May 9, 2011
Last Updated: June 3, 2011
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013