Condition category
Circulatory System
Date applied
15/02/2002
Date assigned
15/02/2002
Last edited
06/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Paracetamol (acetaminophen), ibuprofen

Primary outcome measures

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 trial start date

01/12/2000

Overall trial end date

31/12/2001

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11918829

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12657165

Publication citations

  1. Protocol

    van Breda EJ, van der Worp B, van Gemert M, Meijer R, Kappelle J, Koudstaal PJ, Dippel DW, , PISA. The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: protocol for a phase II double-blind randomised placebo-controlled trial [ISRCTN98608690]., BMC Cardiovasc Disord, 2002, 2, 7.

  2. Results

    Dippel DW, van Breda EJ, van der Worp HB, van Gemert HM, Meijer RJ, Kappelle LJ, Koudstaal PJ, , Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]., BMC Cardiovasc Disord, 2003, 3, 2, doi: 10.1186/1471-2261-3-2.

Additional files

Editorial Notes