Status:
COMPLETED
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST)
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 evaluat...
Detailed Description
Newer thrombolytic agents such as tenecteplase have pharmacological features (higher fibrin binding specificity and longer half-life) that may be advantageous when compared to older agents such as alt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01472926
Start Date
December 1 2011
End Date
December 10 2013
Last Update
August 3 2018
Active Locations (1)
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1
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF