Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

NCT04071613 | Completed Phase 2 DMC

• 1 other identifier: 2018.043
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

Brief Summary

Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital

Conditions

Stroke, Acute, Stroke Ischemic

Outcome Measures

Primary Outcomes (1)

• Perfusion lesion on CTP

  The volume of the perfusion lesion on CTP performed on arrival at the receiving hospital, adjusted for pre-treatment NIHSS and time from initiation of treatment to CTP.

  Within 2hrs of treatment

Secondary Outcomes (12)

• Infarct core growth between baseline CTP and 24 hour MRI.

  24 hrs

• Percent reperfusion between baseline CTP and 24 hour perfusion imaging (MRI)

  24 hrs

• Reduction in NIHSS between pre-treatment score and score on ED arrival, adjusted for pre-treatment NIHSS and time from initiation of treatment to ED NIHSS score

  2 hrs

• Reduction in NIHSS between pre-treatment score and score at 24 hours post treatment, adjusted for pre-treatment NIHSS

  24 hrs

• Modified Rankin Scale (mRS) at 3 months - ordinal analysis adjusted for baseline NIHSS and age

  3 months

Study Arms (2)

Intravenous tenecteplase (TNK)

ACTIVE COMPARATOR

Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \~10 seconds).

Drug: Tenecteplase

Intravenous tissue plasminogen activator (tPA)

ACTIVE COMPARATOR

Patients will receive intravenous t-PA at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.

Drug: Intravenous tissue plasminogen activator (tPA)

Interventions

Tenecteplase DRUG

Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset

Also known as: TNK

Intravenous tenecteplase (TNK)

Intravenous tissue plasminogen activator (tPA) DRUG

Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes) Frequency: once only, within 4.5 hours of stroke onset

Also known as: TPA, Alteplase

Intravenous tissue plasminogen activator (tPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients being attended by the mobile stroke unit with an acute ischemic stroke eligible for thrombolysis using standard clinical and CT criteria.
• Patient's age is ≥18 years
• Premorbid mRS \<4

You may not qualify if:

• Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor) identified by CT on the MSU
• Hypodensity in \>1/3 MCA territory or equivalent proportion of ACA or PCA territory on non-contrast CT on MSU
• Pre-stroke mRS score of \> 3 (indicating significant previous disability)
• Any terminal illness such that patient would not be expected to survive more than 1 year
• Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
• Pregnant women.
• Rapidly improving symptoms.

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (5)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Eastern Health

Melbourne, Victoria, Australia

Location

Western Hospital

Melbourne, Victoria, Australia

Location

Alfred Hopsital

Melbourne, Australia

Location

Monash Health

Melbourne, Australia

Location

Related Publications (2)

• Bivard A, Zhao H, Churilov L, Campbell BCV, Coote S, Yassi N, Yan B, Valente M, Sharobeam A, Balabanski AH, Dos Santos A, Ng JL, Yogendrakumar V, Ng F, Langenberg F, Easton D, Warwick A, Mackey E, MacDonald A, Sharma G, Stephenson M, Smith K, Anderson D, Choi P, Thijs V, Ma H, Cloud GC, Wijeratne T, Olenko L, Italiano D, Davis SM, Donnan GA, Parsons MW; TASTE-A collaborators. Comparison of tenecteplase with alteplase for the early treatment of ischaemic stroke in the Melbourne Mobile Stroke Unit (TASTE-A): a phase 2, randomised, open-label trial. Lancet Neurol. 2022 Jun;21(6):520-527. doi: 10.1016/S1474-4422(22)00171-5. Epub 2022 May 4.

  PMID: 35525251 DERIVED

• Bivard A, Zhao H, Coote S, Campbell B, Churilov L, Yassi N, Yan B, Valente M, Sharobeam A, Balabanski A, Dos Santos A, Ng F, Langenberg F, Stephenson M, Smith K, Bernard S, Thijs V, Cloud G, Choi P, Ma H, Wijeratne T, Chen C, Olenko L, Davis SM, Donnan GA, Parsons M. Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (Mobile Stroke Unit-TASTE-A): protocol for a prospective randomised, open-label, blinded endpoint, phase II superiority trial of tenecteplase versus alteplase for ischaemic stroke patients presenting within 4.5 hours of symptom onset to the mobile stroke unit. BMJ Open. 2022 Apr 29;12(4):e056573. doi: 10.1136/bmjopen-2021-056573.

  PMID: 35487712 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The people assessing the outcomes The people analysing the results/data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, prospective, randomised open-label blinded endpoint (PROBE) phase II study in stroke thrombolysis patients to compare tenecteplase and alteplase for an outcome of less disability at 3 months

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: June 20, 2019
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)