omacor and Thrombosis

The Fish oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial investigated whether 3 months of omega-3 polyunsaturated fatty acids, either alone or in combination with aspirin, will effectively reduce primary access failure of de novo arteriovenous fistulae. This report presents the baseline characteristics of all study participants, examines whether study protocol amendments successfully increased recruitment of a broader and more representative haemodialysis cohort, including patients already receiving aspirin, and contrasts Malaysian participants with those from Australia, New Zealand and the United Kingdom (UK).. This international, randomized, double-blind, placebo-controlled trial included patients older than 19 years with stage 4 or 5 chronic kidney disease currently receiving, or planned within 12 months to receive haemodialysis.. Participants (n = 568) were overweight (28.6 ± 7.3 kg/m(2) ), relatively young (54.8 ± 14.3 years), and predominantly male (63%) with a high prevalence of diabetes mellitus (46%) but low rate of ischaemic heart disease (8%). Sixty one percent were planned for lower arm arteriovenous fistula creation. Malaysian participants (n = 156) were younger (51.8 ± 13.6 years vs 57.1 ± 14.2 years, P < 0.001) with a higher prevalence of diabetes mellitus (65% vs 43%, P < 0.001), but less ischaemic heart disease (5% vs 14%, P < 0.01) compared with the combined Australian, New Zealand and UK cohort (n = 228). Protocol modifications allowing for inclusion of patients receiving aspirin increased the prevalence of co-morbidities compared with the original cohort.. The FAVOURED study participants, while mostly similar to patients in contemporary national registry reports and comparable recent clinical trials, were on average younger and had less ischaemic heart disease. These differences were reduced as a consequence of including patients already receiving aspirin.

Topics: Adult; Aged; Arteriovenous Shunt, Surgical; Aspirin; Australia; Comorbidity; Docosahexaenoic Acids; Double-Blind Method; Drug Combinations; Eicosapentaenoic Acid; Female; Fibrinolytic Agents; Graft Occlusion, Vascular; Humans; Malaysia; Male; Middle Aged; New Zealand; Prevalence; Renal Dialysis; Renal Insufficiency, Chronic; Risk Factors; Severity of Illness Index; Thrombosis; Time Factors; Treatment Outcome; United Kingdom; Vascular Patency

The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design.. The original trial protocol published in 2009 has undergone two major amendments, which were implemented in 2011. Firstly, the primary outcome 'early thrombosis' at 3 months following AVF creation was broadened to a more clinically relevant outcome of 'AVF access failure'; a composite of thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are to examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine the safety of study interventions and assess central venous catheter requirement as a result of access failure.. This multicentre international clinical trial was amended to address the clinically relevant question of whether the usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser extent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly, including patients taking aspirin will enroll a more representative cohort of haemodialysis patients, who are significantly older with a higher prevalence of cardiovascular disease and diabetes which may increase event rates and the power of the study.. Australia & New Zealand Clinical Trial Register (ACTRN12607000569404).

Topics: Arteriovenous Shunt, Surgical; Aspirin; Central Venous Catheters; Docosahexaenoic Acids; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Eicosapentaenoic Acid; Fatty Acids, Omega-3; Fish Oils; Humans; Kidney Failure, Chronic; Platelet Aggregation Inhibitors; Postoperative Complications; Renal Dialysis; Renal Insufficiency, Chronic; Thrombosis

Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20-54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF.. The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding.. This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Our study presents significant differences in the anti-platelet agents used, the study design, and surgical and patient demographics that should contribute further evidence regarding the efficacy of anti-platelet agents.. Australia & New Zealand Clinical Trials Register (ACTRN12607000569404).

Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Arteriovenous Shunt, Surgical; Aspirin; Clinical Protocols; Docosahexaenoic Acids; Double-Blind Method; Drug Combinations; Eicosapentaenoic Acid; Humans; Kidney Failure, Chronic; Multicenter Studies as Topic; Platelet Aggregation Inhibitors; Thrombosis; Vascular Patency

To determine the effects of n-3 PUFAs supplementation on plasma indices of coagulation (fibrinogen), fibrin D-Dimer (an index of thrombogenesis and fibrin turnover), endothelial damage/dysfunction (von Willebrand factor (vWf)), platelet activation (soluble P-selectin (sP-sel)) and inflammation (interleukin-6, IL-6) in patients following acute myocardial infarction.. Open-labelled randomised controlled trial. Seventy-seven post-myocardial infarction (MI) patients stabilized on standard secondary prevention therapy were randomised either to 3 months' treatment with Omacor 1 g/day (n=37) or 'usual care' control (n=40). Plasma levels of fibrinogen, D-Dimer, vWf, sP-sel, IL-6 and plasma viscosity at baseline and after 3 months were determined.. At baseline, there were no significant differences between the groups in all research indices, except vWf levels were higher in patients allocated to Omacor supplementation. After 3 months, there were no significant changes in the levels of any research indices in either the Omacor supplemented or the 'usual care' control patients when compared to baseline. Patients who received Omacor experienced a fall in total cholesterol (p=0.019), total/HDL-cholesterol ratio (p=0.009) and LDL-cholesterol (p=0.023). However, the relative changes in plasma lipids and lipoproteins did not differ between the two groups.. Three-month supplementation of Omacor at 1 g per day in post-MI patients is not associated with an improvement in the levels of peripheral indices of coagulation potential, endothelial function, platelet reactivity and inflammation.

Topics: Dietary Supplements; Docosahexaenoic Acids; Drug Combinations; Eicosapentaenoic Acid; Fatty Acids, Omega-6; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocarditis; Thrombosis; Treatment Outcome