Ischemic Stroke Clinical Trial
— NOR-TESTOfficial title:
Randomised Trial of Tenecteplase vs. Alteplase for Recanalisation in Acute Ischemic Stroke
Verified date | May 2017 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 1050 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | |
Norway | Nordland Hospital | Bodø | |
Norway | Drammen Hospital | Drammen | |
Norway | Førde Central Hospital | Førde | |
Norway | Haugesund Hospital | Haugesund | |
Norway | Molde Hospital | Molde | |
Norway | Akershus University Hospital | Nordbyhagen | |
Norway | Ullevål University Hospital | Oslo | |
Norway | Baerum Hospital | Rud | |
Norway | Telemark Hospital | Skien | |
Norway | Stavanger University Hosital | Stavanger | |
Norway | Tønsberg Hospital | Tønsberg | |
Norway | St. Olav Hospital NTNU | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Lars Thomassen | The Research Council of Norway |
Norway,
Logallo N, Kvistad CE, Nacu A, Naess H, Waje-Andreassen U, Asmuss J, Aamodt AH, Lund C, Kurz MW, Rønning OM, Salvesen R, Idicula TT, Thomassen L. The Norwegian tenecteplase stroke trial (NOR-TEST): randomised controlled trial of tenecteplase vs. alteplase in acute ischaemic stroke. BMC Neurol. 2014 May 15;14:106. doi: 10.1186/1471-2377-14-106. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical: Functional handicap | Excellent outcome defined as mRS 0-1 | 90 days | |
Secondary | Symptomatic cerebral hemorrhage | Haemorrhagic transformation (haemorrhagic infarct / haematoma) as defined by CT (or MRI) | 24-36 hours | |
Secondary | Hemorrhagic transformation | Any hemorrhagic infarct or parenchymal hematoma | 24-36 hours | |
Secondary | Neurological improvement | NIHSS changes from baseline: NIHSS=0 or reduction of =4 NIHSS points | 24 hours | |
Secondary | Clinical: Functional handicap | Ordinal shift analysis of mRS | 90 days | |
Secondary | Safety | Death | 90 days |
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