Tenecteplase to help recovery after an ischemic stroke more than 4.5 hours after last seen well

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 study enrolls adults with acute ischemic stroke or wake-up stroke who were last seen well more than 4.5 hours earlier and who have imaging that suggests brain tissue can still be saved. Participants are randomly assigned to receive a single intravenous injection of tenecteplase or standard medical care with equal chance of assignment. Patients planned for mechanical thrombectomy at the enrolling hospital, those with internal carotid artery occlusion, intracranial hemorrhage, or high bleeding risk are excluded. MRI or CT imaging is used to select eligible patients and functional recovery outcomes are measured to see if tenecteplase improves recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sanatorio Güemes
  Buenos Aires, Argentina Recruiting
• Clinica La Sagrada Familia
  Ciudad Autonoma Buenos Aires, Argentina Recruiting
• Clinica Privada Velez Sarfield
  Córdoba, Argentina Recruiting
• Nuevo Hospital San Roque
  Córdoba, Argentina Recruiting
• Sanatorio Allende
  Córdoba, Argentina Recruiting
• Sanatorio Privado Duarte Quiros De Clinica Colombo SA
  Córdoba, Argentina Recruiting

+208 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

  This study tests whether adding NRICM301, a traditional Chinese medicine formula, to usual care is safe for adults with acute ischemic stroke.

  Recruiting En Chu Kong Hospital · New Taipei City · NCT07900503

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.