NCT01949948

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,050

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2012

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4.3 years

First QC Date

September 21, 2013

Last Update Submit

May 5, 2017

Conditions

Ischemic Stroke

Keywords

treatment, intervention, thrombolysis

Outcome Measures

Primary Outcomes (1)

  • Clinical: Functional handicap

    Excellent outcome defined as mRS 0-1

    90 days

Secondary Outcomes (5)

  • Symptomatic cerebral hemorrhage

    24-36 hours

  • Hemorrhagic transformation

    24-36 hours

  • Neurological improvement

    24 hours

  • Clinical: Functional handicap

    90 days

  • Safety

    90 days

Study Arms (2)

Tenecteplase

ACTIVE COMPARATOR

0.4 mg/kg single bolus intravenously

Drug: Tenecteplase

Alteplase

ACTIVE COMPARATOR

0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously

Drug: Alteplase

Interventions

TenecteplaseDRUG

0.4 mg/kg single bolus intravenously

Also known as: Metalyse
Tenecteplase
AlteplaseDRUG

0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously

Also known as: Actilyse
Alteplase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Ischaemic stroke with measurable deficit on NIH Stroke Scale
  • 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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Nordland Hospital

Bodø, 8092, Norway

Location

Drammen Hospital

Drammen, 3004, Norway

Location

Førde Central Hospital

Førde, 6800, Norway

Location

Haugesund Hospital

Haugesund, 5516, Norway

Location

Molde Hospital

Molde, 6400, Norway

Location

Akershus University Hospital

Nordbyhagen, 1474, Norway

Location

Ullevål University Hospital

Oslo, 0424, Norway

Location

Baerum Hospital

Rud, 1309, Norway

Location

Telemark Hospital

Skien, 3710, Norway

Location

Stavanger University Hosital

Stavanger, 4017, Norway

Location

St. Olav Hospital NTNU

Trondheim, 7006, Norway

Location

Tønsberg Hospital

Tønsberg, 3100, Norway

Location

Related Publications (10)

  • Logallo N, Kvistad CE, Nacu A, Naess H, Waje-Andreassen U, Asmuss J, Aamodt AH, Lund C, Kurz MW, Ronning 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.

    PMID: 24886064BACKGROUND

  • Ronning OM, Nordby L, Logallo N, Kvistad CE, Kristoffersen ES, Ihle-Hansen H, Ihle-Hansen H, Novotny V, Waje-Andreassen U, Naess H, Thomassen L, Thommessen B. Association between blood pressure and outcome in patients with acute ischemic stroke treated with alteplase. J Stroke Cerebrovasc Dis. 2026 Jan;35(1):108518. doi: 10.1016/j.jstrokecerebrovasdis.2025.108518. Epub 2025 Dec 6.

    PMID: 41360194DERIVED

  • Novotny V, Kvistad CE, Naess H, Logallo N, Fromm A, Khanevski AN, Thomassen L. Tenecteplase, 0.4 mg/kg, in Moderate and Severe Acute Ischemic Stroke: A Pooled Analysis of NOR-TEST and NOR-TEST 2A. J Am Heart Assoc. 2023 Oct 17;12(20):e030320. doi: 10.1161/JAHA.123.030320. Epub 2023 Oct 13.

    PMID: 37830342DERIVED

  • Ihle-Hansen H, Sandset EC, Ihle-Hansen H, Hagberg G, Thommessen B, Ronning OM, Kvistad CE, Novotny V, Naess H, Waje-Andreassen U, Thomassen L, Logallo N. Sex differences in the Norwegian Tenecteplase Trial (NOR-TEST). Eur J Neurol. 2022 Feb;29(2):609-614. doi: 10.1111/ene.15126. Epub 2021 Oct 4.

    PMID: 34564893DERIVED

  • Thommessen B, Naess H, Logallo N, Kvistad CE, Waje-Andreassen U, Ihle-Hansen H, Ihle-Hansen H, Thomassen L, Morten Ronning O. Tenecteplase versus alteplase after acute ischemic stroke at high age. Int J Stroke. 2021 Apr;16(3):295-299. doi: 10.1177/1747493020938306. Epub 2020 Jul 6.

    PMID: 32631157DERIVED

  • Ahmed HK, Logallo N, Thomassen L, Novotny V, Mathisen SM, Kurz MW. Clinical outcomes and safety profile of Tenecteplase in wake-up stroke. Acta Neurol Scand. 2020 Nov;142(5):475-479. doi: 10.1111/ane.13296. Epub 2020 Jun 23.

    PMID: 32511749DERIVED

  • Kvistad CE, Novotny V, Kurz MW, Ronning OM, Thommessen B, Carlsson M, Waje-Andreassen U, Naess H, Thomassen L, Logallo N. Safety and Outcomes of Tenecteplase in Moderate and Severe Ischemic Stroke. Stroke. 2019 May;50(5):1279-1281. doi: 10.1161/STROKEAHA.119.025041.

    PMID: 31009339DERIVED

  • Ronning OM, Logallo N, Thommessen B, Tobro H, Novotny V, Kvistad CE, Aamodt AH, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase Versus Alteplase Between 3 and 4.5 Hours in Low National Institutes of Health Stroke Scale. Stroke. 2019 Feb;50(2):498-500. doi: 10.1161/STROKEAHA.118.024223.

    PMID: 30602354DERIVED

  • Logallo N, Novotny V, Assmus J, Kvistad CE, Alteheld L, Ronning OM, Thommessen B, Amthor KF, Ihle-Hansen H, Kurz M, Tobro H, Kaur K, Stankiewicz M, Carlsson M, Morsund A, Idicula T, Aamodt AH, Lund C, Naess H, Waje-Andreassen U, Thomassen L. Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol. 2017 Oct;16(10):781-788. doi: 10.1016/S1474-4422(17)30253-3. Epub 2017 Aug 2.

    PMID: 28780236DERIVED

  • Logallo N, Kvistad CE, Thomassen L. Therapeutic Potential of Tenecteplase in the Management of Acute Ischemic Stroke. CNS Drugs. 2015;29(10):811-8. doi: 10.1007/s40263-015-0280-9.

    PMID: 26387127DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TenecteplaseTissue Plasminogen Activator

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Lars Thomassen, MD PhD Prof.

    Dept. Neurology, Haukeland University HospitalBergen, Norway

    STUDY CHAIR

  • Ulrike Waje-Andreassen, MD PhD Prof.

    Dept. Neurology, Haukeland University Hospital, Bergen

    STUDY DIRECTOR

  • Nicola Logallo, MD PhD

    Dept. Neurology, Haukeland University Hospital, Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant neurologist; Professor

Study Record Dates

First Submitted

September 21, 2013

First Posted

September 25, 2013

Study Start

September 1, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

NO(13)