Low-dose tenecteplase versus standard-dose alteplase for acute ischaemic stroke: an Imaging-Based Efficacy Trial.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000466347

Enrollment

Registered

2008-09-17

Start date

2008-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a trial of thrombolytic (clot-dissolving) treatment for acute stroke comparing the standard medication alteplase to a newer agent, tenecteplase

Interventions

Tenecteplase: given as a single intravenous bolus (over one minute), in one of two doses (0.1mg/kg or 0.25 mg/kg)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Patients presenting with acute ischaemic stroke, onset within previous 6 hours. Fulfilling usual clinical criteria for thrombolytic treatment. Specific additional advanced imaging criteria: Imaging inclusion criteria: CT or MR scanning has excluded intracranial haemorrhage CT angiography (CTA) shows a visible vessel occlusion (complete or partial) – this may be in middle, anterior or posterior cerebral artery, and should be anatomically correlated with the perfusion CT (CTP) lesion CTP or MRI shows >20% ‘mismatch’ between mean transit time (MTT) lesion and cerebral blood volume (CBV) or DWI lesion (i.e. significant penumbral tissue) – this is visually assessed.

Exclusion criteria

Standard clinical exclusion criteria for stroke thrombolysis apply. Specific imaging exclusion criteria: Severe renal impairment - Glomerular filtration rate (GFR) <15 mls/min Contraindication to MRI (pacemaker, aneurysm clips) No perfusion lesion visible and/or no visible vessel occlusion (in middle, anterior, or posterior cerebral arteries) ‘Match’ between cerebral blood volume (CBV) or diffusion-weighted MRI (DWI) lesion and MTT lesion (i.e. no penumbra). Large area of irreversible ischaemia (>1/3 middle cerebral artery territory on CBV, or DWI) Internal carotid occlusion on side of acutely affected hemisphere or carotid ‘T’ thrombus (as this may be more effectively treated with intra-arterial therapy) Evidence of acute brainstem ischaemia

Outcome results