Paracetamol (Acetaminophen) in Stroke 2 (PAIS 2): A double-blind, randomized, placebo-controlled clinical trial of high-dose paracetamol in patients with acute stroke and a body temperature of 36.5°C or above
- Conditions
- Stroke (cerebral infarction and intracerebral hemorrhage)10007963
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 255
- clinical diagnosis of ischemic stroke or intracerebral hemorrhage, confirmed by CT or MRI scan within 24 hours after inclusion in the study
- a measurable deficit on the National Institutes of Health Stroke Scale (NIHSS)
- 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)
- a body temperature of 36.5°C or higher
- age of 18 years or older
- signed informed consent
- a history of liver disease or alcohol abuse
- liver enzymes (ASAT, ALAT, AP or gamma-GT) increased above twice the upper limit of normal values
- allergy to paracetamol
- death appearing imminent at the time of inclusion
- any pre-stroke impairment that has led to dependency (modified Rankin scale (mRS)>2) and therefore interferes with the assessment of functional outcome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the score on the modified Rankin Scale (mRS). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcomes will be poor outcome defined as mRS>2 at 3 months; score<br /><br>on the Barthel index and EQ5D score at 3 months; and body temperature 24 hours<br /><br>after start of treatment.</p><br>