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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01472926
• Date of registration: 14/11/2011
• Prospective Registration: Yes
• Primary sponsor: NHS Greater Glasgow and Clyde
• Public title: Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST) ATTEST
• Scientific title: Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis - Pilot Phase (ATTEST)
• Date of first enrolment: December 2011
• Target sample size: 104
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01472926
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Keith Muir
• Affiliation: The University of Glasgow

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Drug: Tenecteplase

Drug: alteplase

Primary Outcome(s)

Percent penumbral salvage at 24-48h (initial penumbra volume on computed tomography perfusion (CTP) imaging versus 24-48h CT infarct volume. [Time Frame: 48 hours]

Secondary Outcome(s)

Distribution of functional outcome by modified Rankin Scale (mRS) scores at Day 30 [Time Frame: 30 Days]

Proportion of patients with favourable clinical outcome (mRS 0-1) at Day 90 [Time Frame: 90 days]

Average 'home time' by day 90 [Time Frame: 90 Days]

Mortality at Day 90 [Time Frame: 90 Days]

Proportion of patients with favourable clinical outcome (mRS 0-1) at Day 30 [Time Frame: 30 days]

Proportion of patients exhibiting recanalisation (on computed tomography angiography, CTA) 24-48 hours post treatment [Time Frame: 48 hours]

Early clinical improvement 24 hours post treatment [Time Frame: 24 hours]

Distribution of functional outcome scores (mRS) at Day 90 [Time Frame: 90 days]

Proportion of patients with symptomatic intracerebral haemorrhage (SICH) on 24-48 hour CT [Time Frame: 48 hours]

Secondary ID(s)

TSA 2010/04

2010-024541-67

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Glasgow