OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT01367145|
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : August 26, 2014
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 or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: OMACOR Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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|
|Study Start Date :||January 2011|
|Primary Completion Date :||November 2013|
|Study Completion Date :||March 2014|
|Active Comparator: Omacor||
4 capsules OMACOR 1g per day
|Placebo Comparator: Placebo||
4 capsules placebo per day
- change from baseline endothelial function to 3 months [ Time Frame: baseline, 3 months ]measured by flow mediated vasodilation
- change from baseline endothelial function to six months [ Time Frame: baseline, 6 months (3 months after treatment cessation) ]
- change of walking distance (maximum/pain-free)from baseline to three months and six months [ Time Frame: baseline, 3, 6 months ]
- change of inflammatory markers from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
- change of pulse wave velocity from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
- bleeding events [ Time Frame: 1, 3, 6 months ]
- liver enzymes changes [ Time Frame: baseline, 1,3,6 months ]
- change of platelet activation from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367145
|Medical University of Vienna, Department of Internal Medicine II, Division of Angiology|
|Vienna, Austria, 1090|
|Principal Investigator:||Sabine Steiner, Dr.||Medical University of Vienna|