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

Recruiting

Phase 2 Results N/A

Update History

16 Aug '12
A location was updated in Glasgow.
New
The overall status was updated to "Recruiting" at Southern General Hospital.
19 Nov '11
The eligibility criteria were updated.
New
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
Old
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 CNS neoplasm, aneurysm or AVM) on pre-treatment CT - Established hypodensity on pre-treatment brain CT of more than one third of the MCA territory or 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> 185 or diastolic BP> 110 mm Hg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP to these limits - If on warfarin, INR <1.4 - Current prescription of non-warfarin oral anticoagulant drugs - Significant abnormality of coagulation parameters pre-treatment (prolonged INR or 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 (> 2minutes) 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 (eGFR <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