Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial

Logallo, Nicola; Novotný, Vojtěch; Aßmus, Jörg; Kvistad, Christopher Elnan; Alteheld, Lars; Rønning, Ole Morten; Thommessen, Bente; Amthor, Karl-Friedrich; Ihle‐Hansen, Hege; Kurz, Martin; Tobro, Håkon; Kaur, Kamaljit; Stankiewicz, Magdalena; Carlsson, Maria; Morsund, Åse Hagen; Idicula, Titto; Aamodt, Anne Hege; Lund, Christian; Næss, Halvor; Waje‐Andreassen, Ulrike; Thomassen, Lars

doi:10.1016/s1474-4422(17)30253-3

Cited by 376 publications

(361 citation statements)

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“…89,91,169,170 In the largest trial of 1100 subjects, tenecteplase at a dose of 0.4 mg/kg failed to demonstrate superiority and had a safety and efficacy profile similar to that of alteplase in a stroke population composed predominantly of patients with minor neurological impairment (median NIHSS score, 4) and no major intracranial occlusion. 170 Tenecteplase is given as a single IV bolus as opposed to the 1-hour infusion of alteplase.See Table XXXIX 2. In patients under consideration for mechanical thrombectomy, observation after IV alteplase to assess for clinical response should not be performed.…”

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confidence: 99%

2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

Powers¹,

Rabinstein²,

Ackerson³

et al. 2018

Stroke

4,392

2,535

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Background and Purpose-The purpose of these guidelines is to provide an up-to-date comprehensive set of recommendations for clinicians caring for adult patients with acute arterial ischemic stroke in a single document. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators. These guidelines supersede the 2013 guidelines and subsequent updates. Methods-Members of the writing group were appointed by the American Heart Association Stroke Council's Scientific Statements Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained. Members were not allowed to participate in discussions or to vote on topics relevant to their relations with industry. The members of the writing group unanimously approved all recommendations except when relations with industry precluded members voting. Prerelease review of the draft guideline was performed by 4 expert peer reviewers and by the members of the Stroke Council's Scientific Statements Oversight The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. Guidelines for the Early Management of PatientsThis guideline was approved by the American Heart Association Science Advisory and Coordinating Committee on November 29, 2017, and the American Heart Association Executive Committee on December 11, 2017. A copy of the document is available at http://professional.heart.org/statements by using either "Search for Guidelines & Statements" or the "Browse by Topic" area. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@ wolterskluwer.com. Tables) is available The American Heart Association requests that this document be cited as follows: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; on behalf of the American Heart Association Stroke Council. 2018 Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018;49:eXXXeXXX. doi: 10.1161/STR.0000000000000158. Data Supplement 1 (EvidenceThe expert peer review of AHA-commissioned documents (eg, scientific statements, clinical practice guidelines, systematic reviews) is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements. Select the "Guidelines & Statem...

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confidence: 99%

2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

Powers¹,

Rabinstein²,

Ackerson³

et al. 2018

Stroke

4,392

2,535

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“…8 During the recruitment phase of EXTEND-IA TNK, the results of the Norwegian tenecteplase stroke trial (NOR-TEST), in which tenecteplase (at a dose of 0.4 mg per kilogram) was compared with alteplase, were reported. 10 Contrary to results in a previous dose-finding trial, 25 tients with large-vessel occlusion may be beneficial, given the large clot burden, and this dose is being studied in a trial (EXTEND-IA TNK Part 2; ClinicalTrials.gov number, NCT03340493). In conclusion, tenecteplase, which can be administered more rapidly than alteplase before thrombectomy in patients with ischemic stroke, was noninferior to alteplase in restoring perfusion in the territory of a proximal cerebral-artery occlusion.…”

Section: Discussionmentioning

confidence: 99%

“…8 Other trials that did not use imaging-based selection have shown similar clinical outcomes with tenecteplase and alteplase. 9,10 Tenecteplase can be infused more rapidly than alteplase and is less expensive. We conducted the Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK) trial to compare tenecteplase with alteplase in establishing reperfusion in patients before endovascular thrombectomy when it was administered within 4.5 hours after the onset of symptoms.…”

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confidence: 99%

Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke

Campbell¹,

et al. 2018

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BACKGROUNDIntravenous infusion of alteplase is used for thrombolysis before endovascular thrombectomy for ischemic stroke. Tenecteplase, which is more fibrin-specific and has longer activity than alteplase, is given as a bolus and may increase the incidence of vascular reperfusion. METHODSWe randomly assigned patients with ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or alteplase (at a dose of 0.9 mg per kilogram; maximum dose, 90 mg) within 4.5 hours after symptom onset. The primary outcome was reperfusion of greater than 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment. Noninferiority of tenecteplase was tested, followed by superiority. Secondary outcomes included the modified Rankin scale score (on a scale from 0 [no neurologic deficit] to 6 [death]) at 90 days. Safety outcomes were death and symptomatic intracerebral hemorrhage. RESULTSOf 202 patients enrolled, 101 were assigned to receive tenecteplase and 101 to receive alteplase. The primary outcome occurred in 22% of the patients treated with tenecteplase versus 10% of those treated with alteplase (incidence difference, 12 percentage points; 95% confidence interval [CI], 2 to 21; incidence ratio, 2.2; 95% CI, 1.1 to 4.4; P = 0.002 for noninferiority; P = 0.03 for superiority). Tenecteplase resulted in a better 90-day functional outcome than alteplase (median modified Rankin scale score, 2 vs. 3; common odds ratio, 1.7; 95% CI, 1.0 to 2.8; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 1% of the patients in each group. CONCLUSIONSTenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. (Funded by the National Health and Medical Research Council of Australia and others; EXTEND-IA TNK ClinicalTrials.gov number, NCT02388061.) a bs tr ac t

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“…[1][2][3][4] Recently, The Norwegian Tenecteplase Stroke Trial (NOR-TEST) showed similar effect and safety outcomes of 0.4 mg/kg tenecteplase as compared to alteplase 0.9 mg/kg in a more general stroke population including 1100 patients. 5 However, a majority of patients had mild stroke.…”

Section: Introductionmentioning

confidence: 99%

Safety and Outcomes of Tenecteplase in Moderate and Severe Ischemic Stroke

Kvistad

Novotný

Kurz

et al. 2019

Stroke

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Background: Tenecteplase represents a promising alternative to alteplase as thrombolytic treatment in acute ischemic stroke. There is limited data on tenecteplase 0.4 mg/kg in patients with increased stroke severity. We aimed to assess safety and efficacy of tenecteplase 0.4 mg/kg in patients with moderate and severe ischemic stroke.Methods: NOR-TEST was a phase III trial designed to investigate safety and efficacy of tenecteplase 0.4 mg/kg versus alteplase 0.9 mg/kg in ischemic stroke. In this post-hoc analysis, moderate stroke was defined as admission NIHSS 6-14 and severe stroke as NIHSS ≥15. Rates of favorable outcome at 90 days, symptomatic intracerebral hemorrhage (sICH) and mortality after 7 and 90 days were assessed.Results: In patients with moderate stroke (n=261), there were no differences in rates favorable outcome, sICH or mortality between tenecteplase and alteplase. In patients with severe stroke (n=87) there were no differences in outcome, frequency of sICH or mortality at 7 days, but all-cause mortality at 90 days was increased in patients treated with tenecteplase (10 [26.3%] vs. 4 [9.1%], p=0.045). One patient died of sICH in the tenecteplase group and two patients died of sICH in the alteplase group. Conclusion:Rates of favorable outcome and sICH were similar between treatment groups in patients with moderate and severe stroke. Mortality after 90 days was increased in patients with severe stroke receiving tenecteplase. Future studies assessing tenecteplase 0.4 mg/kg should monitor safety parameters closely in patients with severe stroke.

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Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial

Cited by 376 publications

References 23 publications

2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke

Safety and Outcomes of Tenecteplase in Moderate and Severe Ischemic Stroke

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