Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST) (ATTEST)

This is an interventional treatment trial for Stroke focused on measuring acute ischaemic stroke, stroke, thrombolysis, thrombolytic drug therapy, CT perfusion, CT angiography, brain imaging Read More

Inclusion Criteria:

• clinical diagnosis of supratentorial acute ischaemic stroke with score of at least 1 on the NIH Stroke Scale
• male or non pregnant female >=18 years
• within 4.5 hours of onset as defined by time since last known well
• CT perfusion and CT Angiogram examination acquired prior to treatment

Exclusion Criteria:

• Contraindications to thrombolytic drug treatment for stroke

  • Evidence of intracranial haemorrhage or significant non-stroke intracranial pathology (including central nervous system neoplasm, aneurysm or arteriovenous malformation) on pre-treatment CT
  • Established hypodensity on pre-treatment brain CT of more than one third of the middle cerebral artery territory or Alberta Stroke Programme Early CT (ASPECT) Score <4 (sulcal effacement or loss of grey-white differentiation in cortical territories alone are not counted towards ASPECT score)
  • Hypodensity consistent with recent cerebral ischaemia other than the presenting event
  • Very severe stroke (eg NIHSS>25)
  • systolic blood pressure (BP)> 185 or diastolic BP> 110 mm Hg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP to these limits
  • If on warfarin, International Normalised Ratio (INR) <1.4
  • Current prescription of non-warfarin oral anticoagulant drugs
  • Significant abnormality of coagulation parameters pre-treatment (prolonged INR or activated partial thromboplastin time (APTT), or platelet count <100,000/mm3)
  • administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory, or use of therapeutic dose low molecular weight heparin within 48h
  • Clinical history suggestive of subarachnoid haemorrhage even if no blood is evident on CT
  • Risk of bleeding (Major surgery within previous 1 month; intracranial or spinal surgery; recent trauma to the head or cranium; prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks; acute pericarditis and/or subacute bacterial endocarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; active peptic ulceration; any known history of haemorrhagic stroke or stroke of unknown origin; arterial aneurysm and known arteriovenous malformation)
  • Dependent (mRS 3-5) pre-stroke
  • Blood glucose <2 mmol/l or >18 mmol/l
  • Seizure at onset of symptoms unless brain imaging identifies positive evidence of significant brain ischaemia (eg CTA confirmed arterial occlusion, early ischaemic change on plain CT, hypoperfusion on CTP)
  • Pregnancy
• Known impaired renal function (estimated Glomerular Filtration Rate <30 ml/min) precluding contrast CT
• Known allergy to radiological contrast
• History of allergies to active substances in either trial medication, or to excipients including gentamicin
• Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardia failure with severe pulmonary oedema)or with life expectancy <=3 months