Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke

Launched by LARS THOMASSEN · Sep 21, 2013

Keywords

ClinConnect Summary

HYPOTHESIS: 1) Tenecteplase 0.4 mg/kg may be given safely to patients with acute ischaemic stroke \<4½ hours after stroke onset. 2) Tenecteplase 0,4 mg/kg (single bolus)has superior efficacy and safety compared with alteplase 0.9 mg/kg (10% bolus + 90% infusion/60 minutes) when given within 4 ½ hours after stroke onset.

DESIGN: NOR-TEST is a multi-centre PROBE (prospective randomised, open-label, blinded endpoint) trial with randomisation tenecteplase:alteplase 1:1.

POWER CALCULATION: NOR-TEST aims at detecting a 9 % higher percentage excellent outcome with tenecteplase vs. alteplase (r1=...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older
• • Ischaemic stroke with measurable deficit on NIH Stroke Scale
• • All stroke sub-types, severities and vascular distributions,a visible arterial occlusion is not required for inclusion
• • Treatment within 4 ½ hours of stroke onset
• • Patients awakening with symptoms are defined by the time last observed normal and awake
• • Informed written consent signed by the patient, verbal consent from the patients as witnessed by a non-participating health care person, or consent by the signature of the patient's family must be provided
• Exclusion Criteria:
• • Patients with premorbid modified Rankin Scale (mRS) score ≥3
• • Patients for whom a complete NIH Stroke Score cannot be obtained
• • Hemiplegic migraine with no arterial occlusion on CTA
• • Seizure at stroke onset and no visible occlusion on baseline CTA
• • Intracranial haemorrhage on baseline CT
• • Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal
• • Large areas of hypodense ischaemic changes on baseline CT
• • Patients with systolic blood pressure \>185 mm Hg or diastolic blood pressure \>110 mm Hg
• • Female, pregnant or breast feeding
• • Known bleeding diathesis
• • Use of oral anticoagulants and International Normalized Ratio (INR) ≥1,4
• • Use of new oral anticoagulants (NOAC) within the last 12 hours
• • Heparin \<48 hours and increased Activated partial thromboplastin tike (APTT)
• • Low molecular weight heparin(oid) \<24 hours
• • Any other investigational drug \<14 days
• • Sepsis
• • Patients with arterial puncture at a noncompressible site or lumbar puncture \<7 days
• • Major surgery or serious trauma \<14 days
• • Gastrointestinal or urinary tract hemorrhage \<14 days
• • Clinical stroke \<2 months
• • History of intracranial haemorrhage
• • Brain neurosurgery \<2 months
• • Serious head trauma \<2 months
• • Pericarditis
• • Any serious medical illness likely to interact with treatment
• • Confounding pre-existent neurological or psychiatric disease
• • Unlikely to complete follow-up
• • Pregnancy