NCT07361302 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
| NCT ID | NCT07361302 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Boehringer Ingelheim |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,325 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2027-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,325 participants in total. It began in 2026-02-17 with a primary completion date of 2027-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 (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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07361302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07361302 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,325 participants.
Is NCT07361302 currently recruiting?
Yes, NCT07361302 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT07361302 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Ciudad Autonoma Buenos Aires, Argentina, Ciudad Autonoma Buenos Aires, Argentina, Ciudad Autonoma Buenos Aires, Argentina and 11 additional locations.
Who is sponsoring the NCT07361302 clinical trial?
NCT07361302 is sponsored by Boehringer Ingelheim. The trial plans to enroll 1,325 participants.
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