|
ISRCTN
|
ISRCTN74418480
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Paracetamol (Acetaminophen) In Stroke
|
|
Scientific title
|
|
|
Acronym
|
PAIS
|
|
Serial number at source
|
NTR750
|
|
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
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
Acute stroke
|
|
Participants - 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
|
|
Participants - 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])
|
|
Anticipated start date
|
01/05/2003
|
|
Anticipated end date
|
01/09/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
2500
|
|
Interventions
|
Treatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for three days.
|
|
Primary outcome measure(s)
|
Dichotomised mRS (less than or equal to two: good outcome, more than or equal to six: poor outcome) at three months.
|
|
Secondary outcome measure(s)
|
1. Score on the Barthel index after two weeks
2. Body temperature after 24 hours of treatment
3. EuroQol-5D instrument at three months
|
|
Sources of funding
|
Netherlands Heart Foundation; known as 'Early antipyretic therapy in acute stroke trial' (ref 2002B148) (The Netherlands)
|
|
Trial website
|
|
|
Publications
|
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
|
|
Contact name
|
Dr
H
den Hertog
|
|
Address
|
Erasmus Medical Center
Department of Neurology, Suite Ee 2240
P.O. Box 2040
|
|
City/town
|
Rotterdam
|
|
Zip/Postcode
|
3000 CA
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)10 4639222
|
|
Email
|
m.denhertog@erasmusmc.nl
|
|
Sponsor
|
Erasmus Medical Center (The Netherlands)
|
|
Address
|
Department of Neurology
P.O. Box 2040
|
|
City/town
|
Rotterdam
|
|
Zip/Postcode
|
3000 CA
|
|
Country
|
Netherlands
|
|
Date applied
|
06/11/2002
|
|
Last edited
|
10/11/2008
|
|
Date ISRCTN assigned
|
06/11/2002
|
