OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
OMACOR
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Arterial Disease focused on measuring OMEGA-3 polyunsaturated fatty-acids, Peripheral Arterial Disease, Endothelial Function, Inflammation, Platelet Function
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omacor
Placebo
Arm Description
Outcomes
Primary Outcome Measures
change from baseline endothelial function to 3 months
measured by flow mediated vasodilation
Secondary Outcome Measures
change from baseline endothelial function to six months
change of walking distance (maximum/pain-free)from baseline to three months and six months
change of inflammatory markers from baseline to one, three and six months
change of pulse wave velocity from baseline to one, three and six months
bleeding events
liver enzymes changes
change of platelet activation from baseline to one, three and six months
Full Information
NCT ID
NCT01367145
First Posted
May 9, 2011
Last Updated
August 24, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01367145
Brief Title
OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
OMEGA-3 polyunsaturated fatty-acids, Peripheral Arterial Disease, Endothelial Function, Inflammation, Platelet Function
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omacor
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OMACOR
Intervention Description
4 capsules OMACOR 1g per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 capsules placebo per day
Primary Outcome Measure Information:
Title
change from baseline endothelial function to 3 months
Description
measured by flow mediated vasodilation
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
change from baseline endothelial function to six months
Time Frame
baseline, 6 months (3 months after treatment cessation)
Title
change of walking distance (maximum/pain-free)from baseline to three months and six months
Time Frame
baseline, 3, 6 months
Title
change of inflammatory markers from baseline to one, three and six months
Time Frame
baseline, 1, 3, 6 months
Title
change of pulse wave velocity from baseline to one, three and six months
Time Frame
baseline, 1, 3, 6 months
Title
bleeding events
Time Frame
1, 3, 6 months
Title
liver enzymes changes
Time Frame
baseline, 1,3,6 months
Title
change of platelet activation from baseline to one, three and six months
Time Frame
baseline, 1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Steiner, Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
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