ISRCTN ISRCTN74418480
DOI https://doi.org/10.1186/ISRCTN74418480
Secondary identifying numbers NTR750
Submission date
06/11/2002
Registration date
06/11/2002
Last edited
18/02/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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 information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleParacetamol (Acetaminophen) In Stroke
Study acronymPAIS
Study objectivesEarly 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) studiedAcute stroke
InterventionTreatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for three days.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Paracetamol
Primary outcome measureDichotomised mRS (less than or equal to two: good outcome, more than or equal to six: poor outcome) at three months.
Secondary outcome measures1. 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 date01/05/2003
Completion date01/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants2500
Total final enrolment1400
Key inclusion criteria1. 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 criteriaAbody 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 enrolment01/05/2003
Date of final enrolment01/09/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Center (The Netherlands)
Government

Department of Neurology
PO Box 2040
Rotterdam
3000 CA
Netherlands

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

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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