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Paracetamol (Acetaminophen) In Stroke.


- candidate number2200
- NTR NumberNTR750
- ISRCTNISRCTN74418480
- Date ISRCTN created6-nov-2002
- date ISRCTN requested8-nov-2006
- Date Registered NTR7-aug-2006
- Secondary IDsN/A 
- Public TitleParacetamol (Acetaminophen) In Stroke.
- Scientific TitleA multi-center, randomized, double blind, placebo-controlled clinical trial on the effect of paracetamol on functional outcome in acute stroke.
- ACRONYMPAIS
- hypothesisEarly antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic
- Healt Condition(s) or Problem(s) studiedStroke
- Inclusion criteria1. Clinical diagnosis of acute stroke
2. Possibility to start treatment within 12 hours from onset
3. Brain CT or MRI within 24 hours
4. Age 18 years or older
5. Signed informed consent
- Exclusion criteria1. A body temperature lower than 36 degrees Celsius or higher than 39 degrees Celsius
2. A history of liver disease
3. Alcohol abuse
4. Liver enzymes increased above twice the upper limit of normal
5. Allergy to paracetamol
6. Significant pre-stroke impairment (3 on the modified Rankin Scale (mRS))
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mei-2003
- planned closingdate1-sep-2008
- Target number of participants2500
- InterventionsTreatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for 3 days.
- Primary outcomeThe primary outcome measure is the dichotomized mRS (2: good outcome, 3: poor outcome) at 3 months.
- Secondary outcomeSecondary endpoints are the score on the Barthel index after two weeks, body temperature after 24 hours of treatment, and the EuroQol-5D at 3 months.
- Timepoints
- Trial web sitehttp://www.pais-study.org
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H. Hertog, den
- CONTACT for SCIENTIFIC QUERIESDr. D.W.J. Dippel
- Sponsor/Initiator Erasmus Medical Center, Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)
- PublicationsPAPAS, Dippel, van Breda et al., Stroke 2001 PISA, Dippel, van Breda et al., BMC Cardiovascular Disorders, 2003 PAIS protocol, van Breda, van der Worp et al., BMC Cardiovascular Disorders, 2005
- Brief summarySubfebrile temperature and fever in the acute phase of stroke are associated with large infarct volumes, high case fatality and poor functional outcome. A 1C rise in body temperature may double the odds of poor outcome in patients who are admitted within 12 hours from onset of symptoms. Two pilot studies showed that high-dose paracetamol induces a decrease in body temperature of 0.3-0.4C in patients with acute ischemic stroke, even if they are normothermic. This effect occurs within 4 hours after the start of treatment. The purpose of PAIS is to assess whether this decrease in body temperature translates into better clinical outcomes.
- Main changes (audit trail)
- RECORD7-aug-2006 - 7-dec-2006


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