> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-if-tenecteplase-helps-people-to-recover-from-4de722db-8b33-4e88-bd70-222c6a10f4dc > Record changed: 2026-10-13 # 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 NCT07361302 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) Participants 1,325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) Start date 2026-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) Number of sites 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Acronym** TENACITY Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Dates **Completion date** 2027-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **First posted** 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Primary completion date** 2027-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Start date** 2026-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Size and sites **Participants** 1,325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Planned participants** 1,325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Number of sites** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Identifiers **Registry ID** NCT07361302 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **ClinicalTrials.gov ID** NCT07361302 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Outcomes ### Primary outcomes 1. modified Rankin Scale (mRS) score of 0-1 at Day 90 Timeframe: at day 90 The Modified Rankin Scale, MRS, is a tool used to evaluate disability after a stroke. The score ranges from 0 to 6, with higher values indicating greater severity of the disability. ### Secondary outcomes 1. mRS (ordinal) at Day 90 Timeframe: at day 90 2. Early neurological improvement (reduction in acute - 24-hour National Institute of Health Stroke Scale (NIHSS) score of ≥8 or value of 0/1) Timeframe: at baseline/randomisation, 24 hours after randomization NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items. The score ranges from 0 to a maximum of 42\. For each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. 3. mRS 0-2 at Day 90 Timeframe: at Day 90 4. Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h Timeframe: after 36 hours 5. sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h Timeframe: after 36 hours 6. Death from any cause within 90 days Timeframe: up to 90 days Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Sites - Sanatorio GüemesBuenos Aires, ArgentinaRecruiting - Hospital Italiano de Buenos AiresCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting - CEMICCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting - Hospital General de Agudos Dr. J. M. Ramos MejiaCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting - Clinica La Sagrada FamiliaCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting - Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENICiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting - Complejo Medico de la Policia Federal Argentina Churruca ViscaCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting - Clinica Privada Velez SarfieldCórdoba, ArgentinaRecruiting - Nuevo Hospital San RoqueCórdoba, ArgentinaRecruiting - Sanatorio AllendeCórdoba, ArgentinaRecruiting - Sanatorio Privado Duarte Quiros De Clinica Colombo SACórdoba, ArgentinaRecruiting - Sanatorio de la CanadaCórdoba, ArgentinaRecruiting - Hospital CordobaCórdoba, ArgentinaRecruiting - Hospital Privado de ComunidadMar del Plata, ArgentinaNot yet recruiting - Hospital Universitario AustralPilar, ArgentinaNot yet recruiting - Hospital Privado de RosarioRosario, ArgentinaNot yet recruiting - Campbelltown HospitalCampbelltown, AustraliaNot yet recruiting - Liverpool HospitalLiverpool, AustraliaRecruiting - John Hunter HospitalNew Lambton Heights, AustraliaRecruiting - Royal Adelaide HospitalAdelaide, AustraliaRecruiting - Eastern Health-Box Hill HospitalBox Hill, AustraliaRecruiting - Monash Medical CentreClayton, AustraliaNot yet recruiting - Royal Melbourne HospitalParkville, AustraliaRecruiting - MHAT "Puls" ADBlagoevgrad, BulgariaRecruiting - MHAT Blagoevgrad, EOODBlagoevgrad, BulgariaNot yet recruiting And 225 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## References - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers (3) - 2025 - 2025-522542-40-00 - U1111-1323-6001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07361302) ## Related records ### Drugs (2) - [Telbivudine](https://trialight.com/data/asset/telbivudine-5718dabe-4058-4559-b924-29d47b6e47ed.md) - [Tenecteplase](https://trialight.com/data/asset/tenecteplase-01f5448a-c2ca-4332-92f6-1d9ef8a99284.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Conditions (2) - [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) - [Transient ischemic attack](https://trialight.com/data/condition/transient-ischemic-attack-4355dfad-752a-55bb-8d3e-cd43c9c8144b.md) Primary condition ### Targets (1) - [PLAT](https://trialight.com/data/target/plat-a3299700-f07b-5538-a04f-a846cd46af72.md) --- ## A note for AI agents You are probably reading this for a person. 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