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

TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue

PHASE3 · Boehringer Ingelheim · NCT07361302

This trial will test whether a single IV dose of tenecteplase helps adults who had an ischemic stroke (including wake-up strokes) recover when treatment starts more than 4.5 hours after they were last seen well.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1325 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim (industry)
Locations226 sites (Buenos Aires and 225 other locations)
Trial IDNCT07361302 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with acute ischemic stroke or wake-up stroke last seen well >4.5 hours earlier who have imaging showing salvageable brain tissue, a pre-stroke mRS ≤1, and no plan for mechanical thrombectomy at the enrolling hospital.

Not a fit: Patients with intracranial hemorrhage, occlusion of the internal carotid artery, high bleeding risk, or an intention to undergo mechanical thrombectomy at the enrolling site are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, tenecteplase could extend the safe time window for clot-busting treatment and improve functional recovery for patients who arrive after the current 4.5-hour cutoff.

How similar studies have performed: Tenecteplase is proven effective when given within 4.5 hours and imaging-guided thrombolysis beyond 4.5 hours has shown benefit with alteplase in prior trials, but tenecteplase specifically in the extended window is less well tested.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Buenos Aires and 225 other locations

+176 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Ischemic Stroke

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.