2025-522542-40-00
Recruiting
Phase 3
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
Boehringer Ingelheim International GmbH54 sites in 6 countries326 target enrollmentStarted: March 26, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 326
- Locations
- 54
- Primary Endpoint
- mRS 0-1 at Day 90
Overview
Brief Summary
The primary objective of the study is to test the hypothesis that i.v. tenecteplase (0.25 mg/kg, maximum 25 mg) is superior to SOC in achieving excellent functional outcome (modified Rankin Scale (mRS) score of 0-1 at Day 90) in AIS patients who were last known well >4.5 hours before randomisation (including strokes of known and unknown onset, to which wake-up strokes belong) and presenting with a significant volume of salvageable brain tissue on imaging.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. See Section 8.1 for details.
- •Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation, last known well >4.5 h before time of presumed randomisation
- •Pre-stroke mRS ≤1 (to be assessed via medical history)
- •Imaging eligibility by MRI CT
Exclusion Criteria
- •Intention to proceed to MT at the same site (hospital) of randomisation.
- •Other known history of or identified relevant central nervous system damage (i.e., neoplasm, arterial aneurysm and/or arterial/venous malformation, intracranial or spinal surgery) as well as known arterial aneurysm and/or arterial/venous malformations, and/or neoplasms with increased bleeding risk, located outside of the Central Nervous System.
- •Contra-indications to Tenecteplase
- •Occlusion of the internal carotid artery (ICA)
- •High-risk patients (increased risk of thrombolysis related hemorrhage)
- •Any intracranial hemorrhage detected on NCCT or MRI scans
- •Contra-indication to contrast brain imaging with CT and MRI
- •Severe stroke as assessed clinically (NIHSS > 25)
- •Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
- •Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
Arms & Interventions
Metalyse 5 000 units (25 mg) powder for solution for injection
Test
Intervention: Metalyse 5 000 units (25 mg) powder for solution for injection (Drug)
Outcomes
Primary Outcomes
mRS 0-1 at Day 90
mRS 0-1 at Day 90
Secondary Outcomes
- mRS 0-2 at Day 90
- mRS (ordinal) at Day 90
- Early neurological improvement (reduction in acute – 24-hour NIHSS score of ≥8 or value of 0/1)
- sICH as defined by SITS-MOST criteria at 36 h
- sICH as defined by ECASS III criteria at 36 h
- Death from any cause within 90 days
Investigators
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
Study Sites (54)
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