London, United Kingdom 2013 27 Large clinical trials (RCTs) Effects of candesartan in acute stroke on level of care at 6 months A.G. Hornslien1, E.C. Sandset2, E. Berge3 Oslo University Hospital Ullevål, Oslo, NORWAY1, Oslo University Hospital Ullevål, Oslo, NORWAY2, Oslo University Hospital Ullevål, Oslo, NORWAY3 Background The Scandinavian Candesartan Acute Stroke Trial (SCAST) showed no beneficial effect of blood pressure lowering treatment with candesartan in patients with acute stroke and raised blood pressure. The aim of this analysis is to assess the effects of candesartan on level of care at 6 months and to identify variables associated with need of care at 6 months. Methods SCAST is an international multicenter, randomised- and placebo-controlled, double-masked trial of candesartan in 2.029 patients with acute stroke. We used univariate and multivariate binary logistic regression analyses to identify variables that were associated with need of public care (personal as-sistance at home, short-term- or long-term institutionalisation). Results Data on discharge destination was available for 1825 patients (89.9%). In the candesartan group, 232 patients (25.5%) were dependent on public care, compared to 225 (24.6%) in the placebo group (OR 1.05, 95% CI 0.85 – 1.29, p = 0.68, Figure 1). Higher age, lower score on the Scandinavian Stroke Scale, and living alone were significant predictors for the need of public care (Table 1). Conclusion Blood pressure lowering treatment with candesartan had no beneficial effect on the level of care at 6 months. This result is compatible with the results of the main analysis, and support the conclusion that there is no indication for routine blood pressure treatment with candesartan in the acute phase of stroke. Level of public care is crucial for the long-term costs of treatment, and several predictive variables have been identified. A full analysis of long-term cost-effectiveness (3 years) will be pre-sented E-Poster Session Blue Cerebrovasc Dis 2013; 35 (suppl 3)1-854 563 at the conference. Effects of candesartan on level of care at 6 months Table 1 Multivariate logistic regression model for need of public care at 6 months OR 95% CI p-value Treatment with can-desartan 0.96 0.73 – 1.26 0.76 Age 1.10 1.08 – 1.12 < 0.001 SSS 0.89 0.88 – 0.91 < 0.001 Living alone 3.10 2.33 – 4.11 < 0.001 SSS: Scandinavian Stroke Scale 25 Large clinical trials (RCTs) Monitoring Treatment Compliance in Large, Multicenter Clinical Trials in Stroke – The ATACH II Experience R.H. Martin1, Y.Y. Palesch2, W. Zhao3, C. R. Dillon4, A.I. Qureshi5 for the ATACH II Trialists Medical University of South Carolina, Charleston, USA1, Medical University of South Carolina, Charleston, USA2, Medical University of South Carolina, Charleston, USA3, Medical University of South Carolina, Charleston, USA4, University of Minnesota, Minneapolis, USA5 Background: Protocol noncompliance, especially with administration of study intervention, can result in dilution of treatment (trt) effect, potentially rendering a trial to be inappropriately negative. Frequent and consistent monitoring of study intervention administration becomes critical. Large multicenter acute stroke randomized clinical trials (RCTs) present additional challenges to ensure adherence to study trt due to inherent site variability. The ATACH II Trial is a large (N=1280), multinational phase III RCT to determine if intensive SBP reduction (to < 140 mmHg) and maintenance (for 24 hrs) in acute intracerebral hemorrhage results in a reduced proportion of death/disability at 3 months com-pared to current standard guidelines (reduction to 140-180 mmHg). Although straightforward in design, the nature of the trt makes this RCT vulnerable to trt crossovers and to possible dilution of trt effect. Methods: Using real time data collected through a web-based CTMS, WebDCU, tools have been developed to assist in ongoing monitoring of trt compliance. Computerized algorithms supporting these tools are derived from statistical and clinical knowledge of the study protocol, enabling real-time monitoring of noncompliance to trt administration, variability in clinical care, and data quality. Results: Using data from the ATACH II trial, we have developed the capability for real time monitoring of protocol compliance through graphical displays, tabulated output and email alerts and notifications. Illustration of the tools used for real time monitoring and a preliminary quantitative evaluation on the benefit of using these will be presented. Conclusions: Due to the complex nature of large, multisite RCTs, tools that enhance real time monitoring of pro-tocol compliance are essential. The development and implementation of such tools gives trial man-agement the ability to monitor more efficiently and timely, thereby increasing the quality of clinical trial results.
Karger_ESC London_2013
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