Paracetamol (Acetaminophen) In Stroke
ISRCTN | ISRCTN74418480 |
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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
Scientific
Erasmus Medical Center
Department of Neurology, Suite Ee 2240
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Phone | +31 (0)10 4639222 |
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m.denhertog@erasmusmc.nl |
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Government
Government
Department of Neurology
PO Box 2040
Rotterdam
3000 CA
Netherlands
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 | |
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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 |
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.