• Inger R de Ridder, Frank Jan de Jong, Heleen M den Hertog, Hester F Lingsma, H Maarten A van Gemert, A H C M L Tobien Schreuder, Annemieke Ruitenberg, E Lisette Maasland, Ritu Saxena, Peter Oomes, Jordie van Tuijl, Peter J Koudstaal, L Jaap Kappelle, Ale Algra, H Bart van der Worp, and Diederik W J Dippel.
• Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
• Int J Stroke. 2015 Apr 1; 10 (3): 457-62.

RationaleIn the first hours after stroke onset, subfebrile temperatures and fever have been associated with poor functional outcome. In the first Paracetamol (Acetaminophen) in Stroke trial, a randomized clinical trial of 1400 patients with acute stroke, patients who were treated with high-dose paracetamol showed more improvement on the modified Rankin Scale at three-months than patients treated with placebo, but this difference was not statistically significant. In the 661 patients with a baseline body temperature of 37.0 °C or above, treatment with paracetamol increased the odds of functional improvement (odds ratio 1.43; 95% confidence interval: 1.02-1.97). This relation was also found in the patients with a body temperature of 36.5 °C or higher (odds ratio 1.31; 95% confidence interval 1.01-1.68). These findings need confirmation.AimThe study aims to assess the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36.5 °C or above on functional outcome.DesignThe Paracetamol (Acetaminophen) In Stroke 2 trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial. We use a power of 85% to detect a significant difference in the scores on the modified Rankin Scale of the paracetamol group compared with the placebo group at a level of significance of 0.05 and assume a treatment effect of 7%. Fifteen-hundred patients with acute ischemic stroke or intracerebral hemorrhage and a body temperature of 36.5 °C or above will be included within 12 h of symptom onset. Patients will be treated with paracetamol in a daily dose of six-grams or matching placebo for three consecutive days. The Paracetamol (Acetaminophen) In Stroke 2 trial has been registered as NTR2365 in The Netherlands Trial Register.Study OutcomesThe primary outcome will be improvement on the modified Rankin Scale at three-months as analyzed by ordinal logistic regression.DiscussionIf high-dose paracetamol will be proven effective, a simple, safe, and extremely cheap therapy will be available for many patients with acute stroke worldwide.© 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

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