Paracetamol (Acetaminophen) In Stroke

ISRCTN	ISRCTN74418480
DOI	https://doi.org/10.1186/ISRCTN74418480
Secondary identifying numbers	NTR750

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr H den Hertog
Scientific

Erasmus Medical Center
Department of Neurology, Suite Ee 2240
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 4639222
Email	m.denhertog@erasmusmc.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Paracetamol (Acetaminophen) In Stroke
Study acronym	PAIS
Study objectives	Early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Acute stroke
Intervention	Treatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for three days.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Paracetamol
Primary outcome measure	Dichotomised mRS (less than or equal to two: good outcome, more than or equal to six: poor outcome) at three months.
Secondary outcome measures	1. Score on the Barthel index after two weeks 2. Body temperature after 24 hours of treatment 3. EuroQol-5D instrument at three months
Overall study start date	01/05/2003
Completion date	01/09/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2500
Total final enrolment	1400
Key inclusion criteria	1. Clinical diagnosis of acute stroke 2. Possibility to start treatment within 12 hours from onset 3. Brain Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) within 24 hours 4. Age 18 years or older 5. Signed informed consent
Key exclusion criteria	Abody temperature lower than 36¡ãC or higher than 39¡ãC A history of liver disease Alcohol abuse 1. Liver enzymes increased above twice the upper limit of normal 2. Allergy to paracetamol 3. Significant pre-stroke impairment (more than three on the modified Rankin Scale [mRS])
Date of first enrolment	01/05/2003
Date of final enrolment	01/09/2008

Erasmus Medical Center

Rotterdam
3000 CA
Netherlands

Erasmus Medical Center (The Netherlands)
Government

Department of Neurology
PO Box 2040
Rotterdam
3000 CA
Netherlands

"ROR"	https://ror.org/018906e22

Charity

Netherlands Heart Foundation; known as 'Early antipyretic therapy in acute stroke trial' (ref 2002B148) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol in Dutch	04/10/2003		Yes	No
Protocol article	protocol in English	19/08/2005		Yes	No
Protocol article	protocol correction	04/11/2008		Yes	No
Results article	results	01/05/2009	18/02/2021	Yes	No

18/02/2021: Publication reference and total final enrolment added.