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van CCT (UK)

van CCT (UK)

Paracetamol (Acetaminophen) in Stroke 2 (PAIS 2): A randomized clinical trial to investigate the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36,5C or above.

- candidate number8130
- NTR NumberNTR2365
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2010
- Secondary IDsU1111-1124-9185 WHO UTN
- Public TitleParacetamol (Acetaminophen) in Stroke 2 (PAIS 2): A randomized clinical trial to investigate the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36,5C or above.
- Scientific TitleParacetamol (Acetaminophen) in Stroke 2 (PAIS 2): A randomized, placebo-controlled clinical trial of high-dose paracetamol in patients with acute stroke and a body temperature of 36,5C or above.
- hypothesisWe hypothesize that treatment of patients with acute ischemic or hemorrhagic stroke and a body temperature of 36,5C or above with paracetamol in a daily dose of 6 g for three consecutive days, leads to improved functional outcome.

At least 50% of patients with acute stroke have a body temperature over 36,5C. Increased body temperature is related to poor functional outcome. The risk of poor outcome may double with each degree Celsius increase in body temperature.
- Healt Condition(s) or Problem(s) studiedParacetamol, Cerebral bleeding, Ischemic stroke, Body temperature, Inflammation, Functional outcome
- Inclusion criteria1. Clinical diagnosis of ischemic stroke or intracerebral hemorrhage, confirmed by CT or MRI scan within 24 hours after inclusion in the study;
2. A measurable deficit on the National Institutes of Health Stroke Scale (NIHSS);
3. The possibility to start treatment within 12 hours of symptom onset (for patients who noticed symptoms when awaking from sleep, the time last seen well is taken as the time of onset of symptoms);
4. A body temperature of 36,5C or higher;
5. Age of 18 years or older;
6. Signed informed consent.
- Exclusion criteria1. A body temperature lower than 36.5C;
2. A history of liver disease or alcohol abuse;
3. Liver enzymes (ASAT, ALAT, AP or gamma-GT) increased above twice the upper limit of normal values;
4. Allergy to paracetamol;
5. Death appearing imminent at the time of inclusion;
6. Any pre-stroke impairment that has led to dependency (modified Rankin scale (mRS)>2) and therefore interferes with the assessment of functional outcome.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2010
- planned closingdate1-okt-2014
- Target number of participants1500
- InterventionsParacetamol or matching placebo will be administered 6 times daily for three consecutive days; the first 24 hours as suppositories of 1 g, or as 2 tablets of 500 mg per dosage (after swallowing difficulties have been excluded), from 24-72 hours as 2 tablets of 500 mg per dosage.
- Primary outcomeA favorable outcome defined as improvement on the modified Rankin Scale (mRS) at 3 months from stroke onset.
- Secondary outcome1. Poor outcome defined as mRS>2 at 3 months;
2. Barthel index score as an indicator of functional status (ranging from 0-20, 20 indicating no disability and 0 indicating complete dependence) and European Quality of Life-5 dimensions (EQ5D)25 score at 3 months;
3. Body temperature 12-36 hours after start of treatment;
4. Inflammatory markers and genetic variation thereof.
- Timepoints1. Oktober 2010: first inclusion;
2. Juli 2014: final inclusion;
3. Oktober 2014: end of follow-up.
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsDen Hertog HM et al. The Paracetamol (Acetaminophen) In Stroke trial: a multicentre, randomised, placebo-controlled, phase III trial. Lancet Neurol. 2009 May;8(5):434-40.
- Brief summaryIn the Paracetamol (Acetaminophen) in Stroke (PAIS) trial, a double-blind, placebo-controlled randomized clinical trial of 1400 patients with acute stroke, the paracetamol-treated patients (6 g daily, 3 days) showed more improvement on the modified Rankin scale (mRS) at 3 months, yet the difference was not statistically significant. In the 661 patients with a baseline body temperature of 36,5C or above, treatment with paracetamol led to a larger decrease in temperature (0.30C; 95% CI: 0.20-0.40), increased the odds of improvement (OR 1.43; 95% CI: 1.02-1.97) and was associated with a 7% (95% CI: 0-15%, p=0.06) absolute decrease in the risk of poor outcome. These findings need further study.
- Main changes (audit trail)
- RECORD14-jun-2010 - 20-jun-2012

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