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Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525280-40-00
Enrollment
592
Registered
2026-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Brief summary

Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.

Detailed description

mRS 0 to 1 at 90 days, mRS 0 to 2 at 90 days, Any EVT procedure performed, defined as at least one EVT pass, eTICI score of 2b, 2c or 3 on the first angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer), eTICI score of 2b, 2c or 3 on the final angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer)., Change in NIHSS score between baseline (time of randomization) and arrival at EVT-capable stroke center (before EVT)., Improvement in NIHSS score between baseline (time of randomization) and 24-36 hours of ≥8 points or an NIHSS score ≤1 at 24-36 hours., EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L)., Parenchymal hemorrhage type 1 or 2 assessed according to the Heidelberg classification on a follow-up brain imaging within 36 hours of randomization., Any intracranial hemorrhagic transformation according to the Heidelberg classification on a brain imaging within 36 hours of randomization that is causally associated with an NIHSS increase ≥ 4 points, All-cause death at 90 days

Interventions

Sponsors

Fondation A De Rothschild
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.

Secondary

MeasureTime frame
mRS 0 to 1 at 90 days, mRS 0 to 2 at 90 days, Any EVT procedure performed, defined as at least one EVT pass, eTICI score of 2b, 2c or 3 on the first angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer), eTICI score of 2b, 2c or 3 on the final angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer)., Change in NIHSS score between baseline (time of randomization) and arrival at EVT-capable stroke center (before EVT)., Improvement in NIHSS score between baseline (time of randomization) and 24-36 hours of ≥8 points or an NIHSS score ≤1 at 24-36 hours., EuroQol 5-Dimension 3-Level qu

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 26, 2026