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

Recruiting now · Phase 3

Conditions studied: Acute Ischemic Stroke

In brief

This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot. The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke. Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment. Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.

Key facts

Study ID

NCT07361302

Run by

Boehringer Ingelheim

People needed

1325

Starts

2026-02-17

Expected to finish

2027-10-02

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well >4.5 h before time of presumed randomisation
• Pre-stroke modified Rankin scale (mRS) ≤1
• Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)

You may not qualify if…

• Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation
• Occlusion of the internal carotid artery (ICA)
• High-risk patients (increased risk of thrombolysis related hemorrhage)
• Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans
• Contra-indication to contrast brain imaging with CT and MRI
• Severe stroke as assessed clinically (National Institute of Health Stroke Scale (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 intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.

Where it is running

• Eastern Health-Box Hill Hospital — Box Hill, Victoria, Australia (enrolling)
• Cap Med University — Beijing, China (enrolling)
• CEMIC — Ciudad Autonoma Buenos Aires, Argentina
• Clínica La Sagrada Familia — Ciudad Autonoma Buenos Aires, Argentina
• Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI — Ciudad Autonoma Buenos Aires, Argentina
• Complejo Medico de la Policia Federal Argentina Churruca Visca — Ciudad Autonoma Buenos Aires, Argentina
• Nuevo Hospital San Roque — Córdoba, Argentina
• Campbelltown Hospital — Campbelltown, New South Wales, Australia
• Sanatorio Allende — Córdoba, Argentina
• Sanatorio Privado Duarte Quiros De Clinica Colombo SA — Córdoba, Argentina
• Sanatorio de la Canada — Córdoba, Argentina
• Hospital Cordoba — Córdoba, Argentina
• Hospital Privado de Comunidad — Mar del Plata, Argentina
• Hospital Universitario Austral — Pilar, Argentina
• Hospital Privado de Rosario — Rosario, Argentina
• Clinica Privada Velez Sarfield — Córdoba, Argentina
• Liverpool Hospital — Liverpool, New South Wales, Australia
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Hospital General de Agudos Dr. J. M. Ramos Mejia — Ciudad Autonoma Buenos Aires, Argentina
• Monash Medical Centre — Clayton, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• MHAT "Puls" AD — Blagoevgrad, Bulgaria
• MHAT Blagoevgrad, EOOD — Blagoevgrad, Bulgaria
• Hospital Italiano de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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