Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke "NOR-TEST"


Phase 3 Results N/A

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