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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367145
• Other study ID #: OMACOR II - 2011
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2011
• Last updated: August 24, 2014
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• OMACOR
4 capsules OMACOR 1g per day
• Placebo
4 capsules placebo per day

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Internal Medicine II, Division of Angiology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline endothelial function to 3 months	measured by flow mediated vasodilation	baseline, 3 months	No
Secondary	change from baseline endothelial function to six months		baseline, 6 months (3 months after treatment cessation)	No
Secondary	change of walking distance (maximum/pain-free)from baseline to three months and six months		baseline, 3, 6 months	No
Secondary	change of inflammatory markers from baseline to one, three and six months		baseline, 1, 3, 6 months	No
Secondary	change of pulse wave velocity from baseline to one, three and six months		baseline, 1, 3, 6 months	No
Secondary	bleeding events		1, 3, 6 months	Yes
Secondary	liver enzymes changes		baseline, 1,3,6 months	Yes
Secondary	change of platelet activation from baseline to one, three and six months		baseline, 1, 3, 6 months	No