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A study to test if tenecteplase helps people to recover from an acute stroke when given more than 4.5 hours after the person was last seen well
EU CTIS ID: 2025-522542-40-00
What this study is testing
The primary objective of the study is to test the hypothesis that i.v. tenecteplase (0.25 mg/kg, maximum 25 mg) is superior to SOC in achieving excellent functional outcome (modified Rankin Scale (mRS) score of 0-1 at Day 90) in AIS patients who were last known well >4.5 hours before randomisation (including strokes of known and unknown onset, to which wake-up strokes belong) and presenting with a significant volume of salvageable brain tissue on imaging.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. See Section 8.1 for details.
- Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation, last known well >4.5 h before time of presumed randomisation
- Pre-stroke mRS ≤1 (to be assessed via medical history)
- Imaging eligibility by MRI CT
You likely can't join if
- Intention to proceed to MT at the same site (hospital) of randomisation.
- Other known history of or identified relevant central nervous system damage (i.e., neoplasm, arterial aneurysm and/or arterial/venous malformation, intracranial or spinal surgery) as well as known arterial aneurysm and/or arterial/venous malformations, and/or neoplasms with increased bleeding risk, located outside of the Central Nervous System.
- Contra-indications to Tenecteplase
- Occlusion of the internal carotid artery (ICA)
- High-risk patients (increased risk of thrombolysis related hemorrhage)
- Any intracranial hemorrhage detected on NCCT or MRI scans
See the full eligibility criteria
- Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. See Section 8.1 for details.
- Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation, last known well >4.5 h before time of presumed randomisation
- Pre-stroke mRS ≤1 (to be assessed via medical history)
- Imaging eligibility by MRI CT
- Intention to proceed to MT at the same site (hospital) of randomisation.
- Other known history of or identified relevant central nervous system damage (i.e., neoplasm, arterial aneurysm and/or arterial/venous malformation, intracranial or spinal surgery) as well as known arterial aneurysm and/or arterial/venous malformations, and/or neoplasms with increased bleeding risk, located outside of the Central Nervous System.
- Contra-indications to Tenecteplase
- Occlusion of the internal carotid artery (ICA)
- High-risk patients (increased risk of thrombolysis related hemorrhage)
- Any intracranial hemorrhage detected on NCCT or MRI scans
- Contra-indication to contrast brain imaging with CT and MRI
- Severe stroke as assessed clinically (NIHSS > 25)
- Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
- Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
- Patients scheduled to receive i.v. thrombolysis as standard of care
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Argentina
- Indonesia
- China
- Australia
- India
- Kazakhstan
- Malaysia
- Vietnam
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Argentina; Indonesia; China; Australia; India and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.