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
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
-
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.
-
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.
-
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.