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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

RecruitingPhase 3Ages 18 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

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 g

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Tenecteplase
  • Standard of care treatment
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Where

257 sites
Sanatorio Güemes
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, Argentina
Clinica 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
Clinica Privada Velez Sarfield
Córdoba, Argentina

…and 249 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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