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

• Status: Completed
• Trial end date: 2013-12-10
• Target enrollment: 0
• Participant gender: All

Summary

A pilot evaluation of tenecteplase compared to alteplase in acute ischaemic stroke patients currently eligible for intravenous alteplase treatment in a prospective, randomised, blinded outcome evaluation clinical trial using brain imaging as a biomarker.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborator: University of Glasgow
• Treatments: Plasminogen; Tenecteplase; Tissue Plasminogen Activator

Criteria

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