A randomised control trial of omega-3 fatty acid on platelet and endothelial function in patients with peripheral arterial disease
- Conditions
- Intermittent claudication
- Registration Number
- EUCTR2005-001332-69-GB
- Lead Sponsor
- niversity of Aberdeen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
All patients must be able to give fully informed consent, have an ABPI <0.8 and be on aspirin and a statin. If these patients are not on these medications they will be commenced and enrolled 6 weeks later.We wish to determine the adjuvant effects of omega 3 fatty acids in patients with PAD on what is considered to be routine medical therapy. All patients in this study will attend our nurse lead claudication clinic and strict attention will be paid to secondary risk factor prevention as per our local guidelines. These include measures to acheive the target blood pressure (<140/85), screening for diabetes, referral to smoking cessation clinic, nicotine replacement therapy and advice on exercise.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with critical limb ischaemia, liver impairment, abnormal platelet count, diabetes mellitusand those on clopidogrel, warfarin and NSAIDS
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on<br> 1) platelet function<br> 2) markers of endothelial activation<br> ;Secondary Objective: In patients with peripheral arterial disease,to assess the effects of omega 3 fatty acids on flow mediated dilatation;<br> Primary end point(s): 1) platelet function as assessed by flow cytometry and ultegra RPFA<br> 2) endothelial function as assessed by Von Willebrand Factor<br>
- Secondary Outcome Measures
Name Time Method