Paracetamol (Acetaminophen) In Stroke
| ISRCTN | ISRCTN74418480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74418480 |
| Protocol serial number | NTR750 |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | Netherlands Heart Foundation; known as 'Early antipyretic therapy in acute stroke trial' (ref 2002B148) (The Netherlands) |
- 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 |
|---|---|
| m.denhertog@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Paracetamol |
| 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. |
| Key secondary outcome measure(s) |
1. Score on the Barthel index after two weeks |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | 18/02/2021 | Yes | No |
| 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 |
Editorial Notes
18/02/2021: Publication reference and total final enrolment added.
