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
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
- Acute Ischemic Stroke
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Boehringer Ingelheim
- Enrolment target
- 1,325
- Started
- 17 February 2026
- Main results due
- 2 October 2027
- Study sites
- 254
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(254)
Sanatorio Güemes
Buenos Aires, Argentina
Recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Not yet recruiting
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
Not yet recruiting
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, Argentina
Not yet recruiting
Clinica La Sagrada Familia
Ciudad Autonoma Buenos Aires, Argentina
Not yet recruiting
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
Ciudad Autonoma Buenos Aires, Argentina
Not yet recruiting
Complejo Medico de la Policia Federal Argentina Churruca Visca
Ciudad Autonoma Buenos Aires, Argentina
Not yet 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
Sanatorio de la Canada
Córdoba, Argentina
Recruiting
Hospital Cordoba
Córdoba, Argentina
Recruiting
Hospital Privado de Comunidad
Mar del Plata, Argentina
Not yet recruiting
Hospital Universitario Austral
Pilar, Argentina
Recruiting
Hospital Privado de Rosario
Rosario, Argentina
Recruiting
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Not yet recruiting
Liverpool Hospital
Liverpool, New South Wales, Australia
Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Recruiting
Eastern Health-Box Hill Hospital
Box Hill, Victoria, Australia
Recruiting
Monash Medical Centre
Clayton, Victoria, Australia
Not yet recruiting
Royal Melbourne Hospital
Parkville, Victoria, Australia
Recruiting
MHAT "Puls" AD
Blagoevgrad, Bulgaria
Recruiting
MHAT Blagoevgrad, EOOD
Blagoevgrad, Bulgaria
Not yet recruiting
MHAT Heart and brain
Burgas, Bulgaria
Recruiting
MHAT Sv. Ivan Rilski EOOD
Gorna Oryahovitsa, Bulgaria
Recruiting
MHAT City Clinic Saint Georgi Ltd
Montana, Bulgaria
Recruiting
MHAT Heart and brain
Pleven, Bulgaria
Not yet recruiting
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, Bulgaria
Recruiting
UMHAT "Kaspela", EOOD
Plovdiv, Bulgaria
Recruiting
UMHAT "Sv. Georgi", EAD
Plovdiv, Bulgaria
Recruiting
UMHAT Kanev AD
Rousse, Bulgaria
Recruiting
UMHAT "Medika Ruse" OOD
Rousse, Bulgaria
Recruiting
MHAT "Hadzhi Dimitar" OOD
Silven, Bulgaria
Recruiting
MHATNP "Sv. Naum" EAD
Sofia, Bulgaria
Recruiting
University First MHAT-Sofia "St. Joan Krastitel" EAD
Sofia, Bulgaria
Recruiting
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, Bulgaria
Recruiting
Medical Military Academy MHAT Sofia
Sofia, Bulgaria
Not yet recruiting
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, Bulgaria
Recruiting
University Hospital St. Anna
Sofia, Bulgaria
Recruiting
MHAT 'Sv. Anna - Varna' AD
Varna, Bulgaria
Not yet recruiting
The People's Hospital of Anyang City
Anyang, China
Recruiting
Baoji Central Hospital
Baoji, China
Recruiting
Inner Mongolia Baogang Hospital
Baotou, China
Recruiting
Cap Med University
Beijing, China
Recruiting
Peking University Third Hospital
Beijing, China
Recruiting
Hebei Cangzhou Central Hospital
Cangzhou, China
Recruiting
Jilin Cancer Hospital
Changchun, China
Recruiting
Hunan Provincial People's Hospital
Changsha, China
Recruiting
Chengdu Second People's Hospital
Chengdu, China
Recruiting
Chifeng Traditional Chinese and Mongolian Medicine Hospital
Chifeng, China
Recruiting
Daqing Longnan Hospital
Daqing, China
Recruiting
Daqing Oilfield General Hospital
Daqing, China
Recruiting
The First People's Hospital of Foshan
Foshan, China
Recruiting
General Hospital of Fushun Mining Bureau
Fushun, China
Recruiting
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Recruiting
The Second Hospital of Harbin Medical University
Haerbin, China
Not yet recruiting
The First Affiliated Hospital of University of South China
Hengyang, China
Recruiting
Huai'an Second People's Hospital
Huai'an, China
Recruiting
Showing 60 of 254 sites — filter to narrow it down. 183 of the 254 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07361302. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me