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PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2): Results of a Randomized, Double-Blind Placebo-Controlled Clinical Trial.

Abstract：

BACKGROUND AND PURPOSE:Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of ≥36.5°C. In the present trial, we aimed to confirm this finding. METHODS:PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. RESULTS:Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). CONCLUSIONS:Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed. CLINICAL TRIAL REGISTRATION:URL: http://www.trialregister.nl. Unique identifier: NTR2365.

journal_name

Stroke

journal_title

Stroke

authors

de Ridder IR,den Hertog HM,van Gemert HM,Schreuder AH,Ruitenberg A,Maasland EL,Saxena R,van Tuijl JH,Jansen BP,Van den Berg-Vos RM,Vermeij F,Koudstaal PJ,Kappelle LJ,Algra A,van der Worp HB,Dippel DW,Trial Organization.

doi

10.1161/STROKEAHA.116.015957

subject

Has Abstract

pub_date

2017-04-01 00:00:00

pages

977-982

issue

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.116.015957

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2): Results of a Randomized, Double-Blind Placebo-Controlled Clinical Trial.