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

Completed

Phase 3 Results N/A

Update History

10 May '17
The gender criteria for eligibility was updated to "All."
A location was updated in Bergen.
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The overall status was removed for Haukeland University Hospital.
A location was updated in Bodø.
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The overall status was removed for Nordland Hospital.
A location was updated in Drammen.
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The overall status was removed for Drammen Hospital.
A location was updated in Førde.
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The overall status was removed for Førde Central Hospital.
A location was updated in Haugesund.
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The overall status was removed for Haugesund Hospital.
A location was updated in Molde.
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The overall status was removed for Molde Hospital.
A location was updated in Nordbyhagen.
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The overall status was removed for Akershus University Hospital.
A location was updated in Oslo.
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The overall status was removed for Ullevål University Hospital.
A location was updated in Rud.
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The overall status was removed for Baerum Hospital.
A location was updated in Skien.
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The overall status was removed for Telemark Hospital.
A location was updated in Stavanger.
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The overall status was removed for Stavanger University Hosital.
A location was updated in Trondheim.
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The overall status was removed for St. Olav Hospital NTNU.
A location was updated in Tønsberg.
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The overall status was removed for Tønsberg Hospital.
14 Sep '16
A location was updated in Bodø.
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The overall status was removed for Nordland Hospital.
A location was updated in Haugesund.
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The overall status was removed for Haugesund Hospital.
A location was updated in Molde.
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The overall status was removed for Molde Hospital.
A location was updated in Nordbyhagen.
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The overall status was removed for Akershus University Hospital.
A location was updated in Oslo.
New
The overall status was removed for Ullevål University Hospital.
A location was updated in Skien.
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The overall status was removed for Telemark Hospital.
A location was updated in Stavanger.
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The overall status was removed for Stavanger University Hosital.
A location was updated in Trondheim.
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The overall status was removed for St. Olav Hospital NTNU.
28 Oct '15
The description was updated.
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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=0.40; r2=0.49; OR 1.44; power 0.8), and will include 954 patients during 3 years. PATIENT RECRUITMENT: All patients found eligible for thrombolytic therapy are eligible for NOR-TEST, i.e. NOR-TEST changes neither inclusion nor exclusion criteria. The number of patients treated at a participating centre will therefore essentially remain unchanged. Estimated 400 patients are thrombolysed per year in participating centres. Allowing for 20% of patients not being included in NOR-TEST, the total number of patients (n=954) will still be met.
Old
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=0.40; r2=0.49; OR 1.44; power 0.8), and will include 954 patients during 3 years. PATIENT RECRUITMENT: All patients found eligible for thrombolytic therapy are eligible for NOR-TEST, i.e. NOR-TEST changes neither inclusion nor exclusion criteria. The number of patients treated at a participating centre will therefore essentially remain unchanged. Estimated 400 patients are thrombolysed per year in participating centres. Allowing for 20% of patients not being included in NOR-TEST, the total number of patients (n=954) will still be met.
28 Mar '15
The eligibility criteria were updated.
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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
Old
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 before treatment 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 baseline CT - Seizure at stroke onset and no visible occlusion on baseline CT - 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 primary endovascular treatment - 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 - 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
26 Oct '13
Trial name was updated.
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Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke
The Summary of Purpose was updated.
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BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening of the vessel and up to 40% of the patients may remain severely disabled or die, leaving substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may be more effective and may have less bleeding complications than alteplase, and may be the drug of choice also in stroke. HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose that is associated with improved clinical outcome compared with existing treatment options. AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after symptom onset. STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months (effect). Secondary study endpoints are major early clinical improvement (effect) and bleeding complications (safety).
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BACKGROUND: Alteplase (tPA) dissolves blood vessel clots in acute ischemic stroke and is the only approved acute drug treatment <4½ hours of stroke onset. The overall benefit from tPA is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening of the vessel and up to 40% of the patients may remain severely disabled or die, leaving substantial room for improvement. Tenecteplase (TNK), widely used in coronary heart disease, may be more effective and may have less bleeding complications than tPA, and may be the drug of chice also in stroke. HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose that is associated with improved clinical outcome compared with existing treatment options. AIMS: To compare efficacy and safety of tenecteplase (TNK) vs. alteplase (tPA) given <4½ hours after symptom onset. STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months (effect). Secondary study endpoints are major early clinical improvement (effect) and bleeding complications (safety).
The description was updated.
New
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=0.40; r2=0.49; OR 1.44; power 0.8), and will include 954 patients during 3 years. PATIENT RECRUITMENT: All patients found eligible for thrombolytic therapy are eligible for NOR-TEST, i.e. NOR-TEST changes neither inclusion nor exclusion criteria. The number of patients treated at a participating centre will therefore essentially remain unchanged. Estimated 400 patients are thrombolysed per year in participating centres. Allowing for 20% of patients not being included in NOR-TEST, the total number of patients (n=954) will still be met.
Old
HYPOTHESIS: 1) Tenecteplase (TNK) 0.4 mg/kg may be given safely to patients with acute ischaemic stroke <4½ hours after stroke onset. 2) TNK 0,4 mg/kg (single bolus)has superior efficacy and safety compared with alteplase (tPA) 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=0.40; r2=0.49; OR 1.44; power 0.8), and will include 954 patients during 3 years. PATIENT RECRUITMENT: All patients found eligible for thrombolytic therapy are eligible for NOR-TEST, i.e. NOR-TEST changes neither inclusion nor exclusion criteria. The number of patients treated at a participating centre will therefore essentially remain unchanged. Estimated 1200 patients are thrombolysed per year in participating centres. Allowing for 20% of patients not being included in NOR-TEST, the total number of patients (n=954) will still be met.
The eligibility criteria were updated.
New
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 before treatment 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 baseline CT - Seizure at stroke onset and no visible occlusion on baseline CT - 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 primary endovascular treatment - 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 - 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
Old
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 before treatment. 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 baseline CT; Seizure at stroke onset and no visible occlusion on baseline CT; 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 primary endovascular treatment; 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 INR ≥1,7; heparin <48 hours and increased 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; CNS 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.