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. 2018 Aug 21;2018(8):CD010995. doi: 10.1002/14651858.CD010995.pub2

NCT01455935.

Trial name or title WAke up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) trial
Methods Randomised, single‐blinded, controlled trial
Participants 90 participants
Inclusion criteria
  • Age: 18 to 80 years old

  • Ischaemic wake‐up stroke (unknown time of onset but < 24 hours since last seen normal)

  • NIHSS 8 to 22

  • Evidence of penumbra on CT perfusion as mentioned above

  • ASPECTS 7 or more

  • Signed informed consent


Exclusion criteria
  • Evidence of intracranial haemorrhage (intracerebral haematoma, intraventricular haemorrhage, subarachnoid haemorrhage, epidural haemorrhage, acute or chronic subdural haematoma) on the baseline CT

  • Historical mRS of ≥ 2

  • NIHSS < 8 at the time of treatment

  • Positive pregnancy test in women at age of childbearing

  • Intracranial or intraspinal surgery within 3 months

  • Stroke or serious head injury within 3 months

  • History of intracranial haemorrhage

  • Uncontrolled hypertension at time of treatment (e.g. > 185 mmHg systolic or > 110 mmHg diastolic)

  • Seizure at the onset of stroke

  • Active internal bleeding

  • Intracranial neoplasm

  • Arteriovenous malformation or aneurysm

  • Clinical presentation suggesting post‐myocardial infarction pericarditis

  • Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an INR > 1.7

  • INR > 1.7

  • Administration of heparin within 48 hours preceding the onset of stroke with an elevated aPTT at presentation

  • Platelet count < 100,000/mm3

  • Major surgery within 2 weeks

  • Gastrointestinal or urinary tract haemorrhage within 3 weeks

  • Aggressive treatment required to lower blood pressure

  • Glucose level < 50 or > 400 mg/dL

  • Arterial puncture at a non‐compressible site or lumbar puncture within 1 week

Interventions
  • Best medical care

  • Intravenous tissue plasminogen activator (alteplase) 0.9 mg/kg body weight up to a maximum of 90 mg, 10% as bolus, 90% over 1 hour as infusion

  • Intra‐arterial therapy (choice of intra‐arterial therapy by endovascular surgeon)

Outcomes mRS at 90 days' follow‐up
Starting date November 2011
Contact information Principal Investigator: Tareq Kass‐Hout, Jacobs Neurological Institute, University at Buffalo Neurosurgery, USA
E‐mail: kasshouttareq@gmail.com
Notes ClinicalTrials.gov identifier: NCT01455935