Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

Ischemic Stroke Clinical Trial

— EXTEND-IA TNK  

Official title:

Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388061
• Other study ID #: NTA1401
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2015
• Last updated: March 28, 2018
• Start date: March 23, 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Neuroscience Trials Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 2018
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset

2. Patient's age is =18 years

3. Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.

4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery.

Exclusion Criteria:

1. Intracranial hemorrhage (ICH) identified by CT or MRI

2. Rapidly improving symptoms at the discretion of the investigator

3. Pre-stroke mRS score of = 4 (indicating previous disability)

4. Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT

5. Contra indication to imaging with contrast agents

6. Any terminal illness such that patient would not be expected to survive more than 1 year

7. 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.

8. Pregnant women

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Tenecteplase

• Tissue Plasminogen Activator

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Brisbane & Women's Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Gold Coast University Hospital	Gold Coast	Queensland
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Western Heath	St Albans	Victoria
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Auckland Hospital	Grafton	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Neuroscience Trials Australia	The Florey Institute of Neuroscience and Mental Health

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with substantial angiographic reperfusion (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) or absence of retrievable thrombus at initial angiogram.		Initial angiogram (day 0)
Secondary	Proportion of patients with =8 point reduction in NIHSS or reaching 0-1 at 3 days (favourable clinical response) adjusted for baseline NIHSS and age.		Initial angiogram (day 0)
Secondary	Modified Rankin Scale (mRS) at 3 months	ordinal analysis	3 months post stroke
Secondary	mRS 0-1 or no change from baseline at 3 months		3 months post stroke
Secondary	mRS 0-2 or no change from baseline at 3 months		3 months post stroke
Secondary	Symptomatic intracranial hemorrhage (SICH)		within 36 hours post treatment
Secondary	Death due to any cause		Up to 3 months post stroke
Secondary	Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram		Up to 24 hours post treatment