• Heleen M den Hertog, H Bart van der Worp, H Maarten A van Gemert, Ale Algra, L Jaap Kappelle, Jan van Gijn, Peter J Koudstaal, Diederik W J Dippel, and PAIS Investigators.
• Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. m.denhertog@erasmusmc.nl
• Bmc Cardiovasc Disor. 2008 Jan 1;8:29.

BackgroundThe Paracetamol (Acetaminophen) In Stroke (PAIS) study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever.The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS) may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis.MethodsInstead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial.ConclusionThe protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power.Trial RegistrationCurrent Controlled Trials [ISCRTN74418480].

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