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London, United Kingdom 2013 6 Large clinical trials (RCTs) C 12:40 - 12:50 A cluster randomised controlled trial and cost–effectiveness analysis of a structured train-ing programme for caregivers of in–patients after stroke (TRACS) A. Forster1, J. Dickerson2, J. Young3, A. Patel4, L. Kalra5, J. Nixon6, D. Smithard7, M. Knapp8, I. Holloway9, S. Anwar10, A. Farrin11 University of Leeds and Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KINGDOM1,University of Leeds and Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KINGDOM2, University of Leeds and Bradford Teaching Hospitals NHS Trust, Brad-ford, UNITED KINGDOM3, King’s College London, London, UNITED KINGDOM4, King’s College London, London, UNITED KINGDOM5, University of Leeds, Leeds, UNITED KING-DOM6, King’s College London, London, UNITED KINGDOM7, London School of Economics and Political Science, London, UNITED KINGDOM8, University of Leeds, Leeds, UNITED KINGDOM9,University of Leeds, Leeds, UNITED KINGDOM10, University of Leeds, Leeds, UNITED KINGDOM11 Background: Most stroke patients are dependent on informal caregivers for activities of daily living. The TRACS trial investigated a training programme for caregivers (the London Stroke Caregivers Training Course (LSCTC)) on physical and psychological outcomes, including cost–effectiveness, for patients and caregivers after disabling stroke. Methods: A pragmatic, multicentre, cluster randomised controlled trial with a parallel cost–ef-fectiveness analysis was undertaken. Stroke Units (SUs) were randomised to the LSCTC or usual care. Patients with a diagnosis of stroke, likely to return home with residual disability and with a caregiver providing support were eligible. The primary outcomes were patient self–re-ported extended activities of daily living and caregiver burden at 6 months. Secondary out-comes assessed physical and psychological wellbeing at 6 and 12 months. Patient and caregiver costs were combined with primary outcomes and quality–adjusted life years to assess cost–ef-fectiveness. Cerebrovasc Dis 2013; 35 (suppl 3)1-854 193 Results: Thirty–six SUs registered 928 patient and caregiver dyads. No differences in prima-ry outcomes were found between the groups at 6 months. Adjusted between–group mean dif-ferences were -0•2 points (95% confidence interval (CI) -3•0 to 2•5; p=0•866) for the patient Nottingham Extended Activities of Daily Living score and 0•5 points (95% CI -1•8 to 2•7; p=0•675) for the Caregiver Burden Scale. No differences were detected in secondary out-comes. Patient costs were similar in both groups and caregiver costs were higher in the inter-vention group (adjusted mean difference £207; 95% CI 5 to 408, p=0•045). Probabilities of cost–effectiveness based on QALYs were low. Conclusions: We have demonstrated no differences between the LSCTC and usual care on any of the assessed outcomes. Our parallel process evaluation explored the challenges of LSCTC implementation and the reasons for lack of effectiveness. 5 Large clinical trials (RCTs) C 12:30 - 12:40 Results of the Aortic Arch Related Cerebral Hazard (ARCH) trial P. AMARENCO1, M.R. MacLeod2, F. Mentré3, E.F. Jones4, A.A. Cohen5, D. Young6, M. Kaste7, S.M. Davis8, G.A. Aortic arch Cerebral Related Hazard (ARCH) trial investigators BIchat Stroke Center, INSERM-U698 and Paris-Diderot Sorbonne University, Paris, FRANCE1,, , UNITED KINGDOM2, FRANCE3, AUSTRALIA4, FRANCE5, AUSTRA-LIA6, FINLAND7, AUSTRALIA8, AUSTRALIA9 Background: The risk of recurrent brain infarction, myocardial infarction, peripheral event and vascular death in stroke patients with aortic arch plaque ≥4 mm is 3.5 fold higher than in pa-tients with no plaque, independent of the presence of atrial fibrillation, carotid stenosis, periph-eral arterial disease or other risk factors. We studied a combination of dual antiplatelet versus oral anticoagulant therapy on top of best medical care in prevention of stroke, vascular events and vascular death of these patients. Methods: We compared benefits of clopidogrel 75 mg/ day plus aspirin 75-150 mg/day to warfarin INR 2 to 3, with a PROBE design. Patients with ischemic stroke or peripheral emboli with thoracici aortic plaques ≥4mm in the previous 6 months were eligible. Patients were excluded in case of a known cause of stroke or an absolute indication for warfarin or clopidogrel plus aspirin. The hypothesis was that the net benefit of dual antiplatelet therapy was 25% superior to that of warfarin. With an alpha risk of 5%, power of 90%, two years for inclusion and 3 more years for follow-up, a risk of 14% in the warfa-rin group, a 15% drop-out rate, The estimated sample size was 756 patients with a maximum of 1488 patients. Primary end-point was a composite of recurrent stroke (brain infarction and brain hemorrhage), myocardial infarction, peripheral embolism (renal, splenic and mesenter-ic infarction, cholesterol embolism and above ankle amputation) and vascular death. Results: Between February 2002 and May 2010, 345 patients were randomized in France, Australia and Switzerland (174 on warfarin and 171 on clopidogrel plus aspirin. Randomization was stopped due to lack of funding. Mean age of patients was 69.6 ±9.2 years and 71.6% of them were men. Follow-up was 39.3±22.7 months. The statistical analyses are underway and final results will be presented at the meeting. Conclusion: The aim of the study could not be reached due to pre-maturely closed enrollment of patients.


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