No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,325 (estimated)
Sponsor
Boehringer Ingelheim · Industry
Who this trial is looking for
This trial is looking for adults who have had an acute stroke caused by a clot and were last seen well more than 4.5 hours ago. Participants will receive either a medication called tenecteplase or standard treatment to see how it helps recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have provided signed consent to join the study.
I have had an acute ischemic stroke or woke up with stroke symptoms.
More than 4.5 hours have passed since I was last seen well.
My pre-stroke disability level was 1 or less.
I have had imaging that shows there is brain tissue that can still be saved.
You may not be able to join if
I am scheduled for a procedure to remove the blood clot.
I have an occlusion of the internal carotid artery.
I have a high risk of bleeding complications.
I have any signs of bleeding in the brain.
I am unable to undergo brain imaging.
My stroke severity is very high.
I have non-disabling stroke symptoms or symptoms that are quickly improving.
I have imaging results that do not indicate a recent stroke.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion criteria:
1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Acute ischaemic stroke (includ…
Inclusion criteria:
1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. 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
4. Pre-stroke modified Rankin scale (mRS) ≤1
5. Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)
Exclusion criteria:
1. Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation
2. Occlusion of the internal carotid artery (ICA)
3. High-risk patients (increased risk of thrombolysis related hemorrhage)
4. Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans
5. Contra-indication to contrast brain imaging with CT and MRI
6. Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \> 25)
7. Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
8. Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
9. Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.
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