Contact information
Type
Scientific
Contact name
Dr Diederik WJ Dippel
ORCID ID
Contact details
Dept of Neurology
University Hospital Rotterdam
PO Box 2040
Rotterdam
3000 CR
Netherlands
+31 (0)10 4639222
dippel@neuro.fgg.eur.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PISA
Study hypothesis
To study the effect of high-dose ibuprofen and to confirm the previously observed reducing effect of high-dose paracetamol on body temperature, and to study their safety in normothermic and subfebrile patients with acute ischaemic stroke.
Ethics approval(s)
The medical ethics committees of the three hospitals have approved this protocol.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Stroke
Intervention
1. Paracetamol 6 g daily, for 5 days
2. Ibuprofen 2.4 g daily, for 5 days
3. Placebo for 5 days
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Paracetamol (acetaminophen), ibuprofen
Primary outcome measure
Body temperature at 24 hours from start of treatment.
Secondary outcome measures
1. Change in baseline temperature at 1 and 5 days from start of treatment
2. Time with elevated body temperature (greater than 37.0°C) (area under the curve) during the first 24 hours and the first five days
Tertiary outcomes:
Functional outcome at one month, as determined by the scores on the modified Rankin Scale (mRS) and Barthel Index (BI).
Overall study start date
01/12/2000
Overall study end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. An acute ischaemic anterior circulation stroke
2. A body temperature greater than 36.0°C or less than 39.0°C
3. A CT scan that is compatible with acute ischaemic stroke
4. A focal deficit without rapid improvement
5. A possibility to start treatment within 24 hours after stroke onset
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
75
Participant exclusion criteria
1. Severe aphasia, defined as an aphasia score of 2 or 3 on the National Institutes of Health Stroke Scale (NIHSS)
2. Treatment with an non-Steroidal Anti-Inflammatory Drug (NSAID) deemed necessary
3. Hypersensitivity to ibuprofen or paracetamol
4. (Chronic) liver failure or cirrhosis
5. (Chronic) renal failure
6. History of alcohol abuse
7. Active gastric ulcer disease or a history of peptic ulceration or gastro-intestinal haemorrhage in the preceding year
8. Colitis ulcerosa
9. Pregnancy
10. Use of corticosteroids
11. A severe concomitant medical condition that could affect the assessment of the effect of the study medication on temperature
12. Residual neurological impairment resulting from a previous stroke that may hamper the assessment of functional outcome
13. Death appearing imminent
14. No informed consent given
Recruitment start date
01/12/2000
Recruitment end date
31/12/2001
Locations
Countries of recruitment
Netherlands
Study participating centre
Dept of Neurology
Rotterdam
3000 CR
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.erasmusmc.nl/content/englishindex.htm
ROR
Funders
Funder type
Research organisation
Funder name
Rotterdam Neurovascular Research Foundation (Stichting Neurovasculair Onderzoek Rotterdam) (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 27/03/2002 | Yes | No | |
| Results article | Results | 06/02/2003 | Yes | No |