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.
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
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
Parallel
Tenecteplase
DrugTenecteplase
Standard of care treatment
DrugStandard of care treatment
modified Rankin Scale (mRS) score of 0-1 at Day 90
The Modified Rankin Scale, MRS, is a tool used to evaluate disability after a stroke. The score ranges from 0 to 6, with higher values indicating greater severity of the disability.
mRS (ordinal) at Day 90
Early neurological improvement (reduction in acute - 24-hour National Institute of Health Stroke Scale (NIHSS) score of ≥8 or value of 0/1)
NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items. The score ranges from 0 to a maximum of 42. For each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
mRS 0-2 at Day 90
Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h
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