OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
NCT ID: NCT01367145
Last Updated: 2014-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2011-01-31
2014-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Omacor
OMACOR
4 capsules OMACOR 1g per day
Placebo
Placebo
4 capsules placebo per day
Interventions
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OMACOR
4 capsules OMACOR 1g per day
Placebo
4 capsules placebo per day
Eligibility Criteria
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Inclusion Criteria
* Ankle Brachial Index\<0.9
* Age ≥18 years
* Adequate PAD therapy according to current AHA guidelines
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Sabine Steiner
Prof.
Principal Investigators
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Sabine Steiner, Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
Vienna, , Austria
Countries
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Other Identifiers
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OMACOR II - 2011
Identifier Type: -
Identifier Source: org_study_id
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