Condition category
Circulatory System
Date applied
06/11/2002
Date assigned
06/11/2002
Last edited
10/11/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H den Hertog

ORCID ID

Contact details

Erasmus Medical Center
Department of Neurology
Suite Ee 2240
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4639222
m.denhertog@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR750

Study information

Scientific title

Acronym

PAIS

Study hypothesis

Early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Paracetamol

Primary outcome measures

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 trial start date

01/05/2003

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

2500

Participant 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])

Recruitment start date

01/05/2003

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Department of Neurology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2003 protocol in Dutch in http://www.ncbi.nlm.nih.gov/pubmed/14574783
2. 2005 protocol in English in http://www.ncbi.nlm.nih.gov/pubmed/16109181
3. 2008 protocol correction in http://www.ncbi.nlm.nih.gov/pubmed/18983661

Publication citations

  1. Protocol in Dutch

    van Breda EJ, van der Worp HB, van Gemert HM, Dippel DW, [Treatment of stroke by reducing the body temperature; 'Paracetamol (acetaminophen) in stroke' (PAIS): start of a clinical trial]., Ned Tijdschr Geneeskd, 2003, 147, 40, 1976-1978.

  2. Protocol in English

    van Breda EJ, van der Worp HB, van Gemert HM, Algra A, Kappelle LJ, van Gijn J, Koudstaal PJ, Dippel DW, , PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial [ISCRTN 74418480]., BMC Cardiovasc Disord, 2005, 5, 24, doi: 10.1186/1471-2261-5-24.

  3. Protocol correction

    den Hertog HM, van der Worp HB, van Gemert HM, Algra A, Kappelle LJ, van Gijn J, Koudstaal PJ, Dippel DW, , Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480]., BMC Cardiovasc Disord, 2008, 8, 29, doi: 10.1186/1471-2261-8-29.

Additional files

Editorial Notes