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

Boehringer Ingelheim

Status and phase

Begins enrollment this month

Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: Tenecteplase

Drug: Standard of care treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT07361302

1123-0060

2025-522542-40-00 (EU Trial (CTIS) Number)

U1111-1323-6001 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

1,325 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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
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)

Exclusion criteria

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.