Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

Sponsors

Lead Sponsor: Melbourne Health

Source Melbourne Health
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

Detailed Description

Currently, alteplase is the standard clot-dissolving therapy for ischemic stroke, however this treatment is only effective in 30-45% of patients. Importantly, treatment of ischemic stroke is more effective when given within 90 minutes of stroke onset. Means of treating patients earlier with more effective therapies are needed. Ischemic stroke is a major public health problem, for which effective and accessible drug therapies remain limited. Current management of acute ischemic stroke includes treatment with a solution called alteplase, which dissolves clots in a cerebral artery. The treatment effect of alteplase is much greater if given within 90 minutes of stroke onset. As a result, there has been a significant push to take stroke care to the patient in the form of the Mobile Stroke Unit (MSU). The MSU is the first designed as a CT-capable ambulance that allows assessment and treatment of stroke patients in the pre-hospital setting. In the proposed research project, we will undertake a clinical trail investigating the effectiveness of a new thrombolytic agent in the MSU, tenecteplase. Tenecteplase has been shown to be significantly more effective at improving stroke survivor's recovery and opening blocked blood vessels than alteplase in the hospital setting. However, it is unknown if earlier administration of tenecteplase is more effective than early administration of alteplase. The tested agent, tenecteplase, is cheaper, easier to administer (no time-consuming infusions required) and more practical for an ambulance delivered therapy than the current standard of care alteplase. If tenecteplase results in better clinical outcomes in addition to these practical advantages, there is significant scope for improved patient outcomes and cost savings.

Overall Status Recruiting
Start Date 2019-06-20
Completion Date 2021-12-30
Primary Completion Date 2021-06-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Perfusion lesion on CTP Within 2hrs of treatment
Secondary Outcome
Measure Time Frame
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
mRS 0-2 or no change from baseline at 3 months adjusted for baseline NIHSS and age 3 months
Proportion of patients where thrombolytic medication is initiated within 5 minutes of completion of CT on the MSU. 24 hrs
Time from completion of CT on the MSU to initiation of thrombolysis (CT to needle time) 2 hrs
mRS 5-6 at 3 months adjusted for baseline NIHSS and age 3 months
Death due to any cause adjusted for baseline NIHSS and age During time on study up to 3 months
Any parenchymal haematoma During time on study up to 3 months
ymptomatic intracranial hemorrhage (sICH) During time on study up to 3 months
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tenecteplase

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

Arm Group Label: Intravenous tenecteplase (TNK)

Other Name: TNK

Intervention Type: Drug

Intervention Name: Intravenous tissue plasminogen activator (tPA)

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

Arm Group Label: Intravenous tissue plasminogen activator (tPA)

Other Name: TPA, Alteplase

Eligibility

Criteria:

Inclusion Criteria: 1. Patients being attended by the mobile stroke unit with an acute ischemic stroke eligible for thrombolysis using standard clinical and CT criteria. 2. Patient's age is ≥18 years 3. Premorbid mRS <4 Exclusion Criteria: 1. Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor) identified by CT on the MSU 2. Hypodensity in >1/3 MCA territory or equivalent proportion of ACA or PCA territory on non-contrast CT on MSU 3. Pre-stroke mRS score of > 3 (indicating significant previous disability) 4. Any terminal illness such that patient would not be expected to survive more than 1 year 5. 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. 6. Pregnant women. 7. Rapidly improving symptoms.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Mark Parsons, BMed, PhD

Phone: 61 3 9342 7000

Phone Ext.: 28448

Email: [email protected]

Location
Facility: Status: Contact:
Royal Melbourne Hospital | Melbourne, Victoria, 3050, Australia Recruiting Amy McDonald 393424424 [email protected]
Eastern Health | Melbourne, Victoria, Australia Recruiting Phillip Choi
Western Hospital | Melbourne, Victoria, Australia Recruiting Sherisse Celentino
Alfred Hopsital | Melbourne, Australia Recruiting Geoff Cloud
Monash Health | Melbourne, Australia Recruiting Henry Ma
Location Countries

Australia

Verification Date

2020-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intravenous tenecteplase (TNK)

Type: Active Comparator

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

Label: Intravenous tissue plasminogen activator (tPA)

Type: Active Comparator

Description: 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.

Acronym TASTEa
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: The people assessing the outcomes The people analysing the results/data

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