Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK)
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ClinicalTrials.gov Identifier: NCT02388061 |
Recruitment Status :
Completed
First Posted : March 13, 2015
Last Update Posted : March 30, 2018
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Drug: Tenecteplase Drug: Tissue Plasminogen Activator | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 202 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase |
Actual Study Start Date : | March 23, 2015 |
Actual Primary Completion Date : | October 16, 2017 |
Actual Study Completion Date : | February 2018 |

Arm | Intervention/treatment |
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Experimental: Intravenous tenecteplase (TNK)
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).
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Drug: Tenecteplase
Other Name: TNK |
Active Comparator: Intravenous tissue plasminogen activator (tPA)
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.
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Drug: Tissue Plasminogen Activator
Other Names:
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- 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. [ Time Frame: Initial angiogram (day 0) ]
- 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. [ Time Frame: Initial angiogram (day 0) ]
- Modified Rankin Scale (mRS) at 3 months [ Time Frame: 3 months post stroke ]ordinal analysis
- mRS 0-1 or no change from baseline at 3 months [ Time Frame: 3 months post stroke ]
- mRS 0-2 or no change from baseline at 3 months [ Time Frame: 3 months post stroke ]
- Symptomatic intracranial hemorrhage (SICH) [ Time Frame: within 36 hours post treatment ]
- Death due to any cause [ Time Frame: Up to 3 months post stroke ]
- Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram [ Time Frame: Up to 24 hours post treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
- Patient's age is ≥18 years
- Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.
- Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery.
Exclusion Criteria:
- Intracranial hemorrhage (ICH) identified by CT or MRI
- Rapidly improving symptoms at the discretion of the investigator
- Pre-stroke mRS score of ≥ 4 (indicating previous disability)
- Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT
- Contra indication to imaging with contrast agents
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388061

Responsible Party: | Neuroscience Trials Australia |
ClinicalTrials.gov Identifier: | NCT02388061 |
Other Study ID Numbers: |
NTA1401 |
First Posted: | March 13, 2015 Key Record Dates |
Last Update Posted: | March 30, 2018 |
Last Verified: | March 2018 |
Stroke Ischemic Stroke Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Pathologic Processes Tissue Plasminogen Activator Plasminogen Tenecteplase Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |