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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
Sponsor: Boehringer Ingelheim
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1325
Start Date
2026-02-17
Completion Date
2027-10-02
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Tenecteplase
Tenecteplase
Standard of care treatment
Standard of care treatment
Locations (257)
Sanatorio Güemes
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, Argentina
Clinica La Sagrada Familia
Ciudad Autonoma Buenos Aires, Argentina
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
Ciudad Autonoma Buenos Aires, Argentina
Complejo Medico de la Policia Federal Argentina Churruca Visca
Ciudad Autonoma Buenos Aires, Argentina
Clinica Privada Velez Sarfield
Córdoba, Argentina
Nuevo Hospital San Roque
Córdoba, Argentina
Sanatorio Allende
Córdoba, Argentina
Sanatorio Privado Duarte Quiros De Clinica Colombo SA
Córdoba, Argentina
Sanatorio de la Canada
Córdoba, Argentina
Hospital Cordoba
Córdoba, Argentina
Hospital Privado de Comunidad
Mar del Plata, Argentina
Hospital Universitario Austral
Pilar, Argentina
Hospital Privado de Rosario
Rosario, Argentina
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
MHAT "Puls" AD
Blagoevgrad, Bulgaria
MHAT Blagoevgrad, EOOD
Blagoevgrad, Bulgaria
MHAT Heart and brain
Burgas, Bulgaria
MHAT Sv. Ivan Rilski EOOD
Gorna Oryahovitsa, Bulgaria
MHAT City Clinic Saint Georgi Ltd
Montana, Bulgaria
MHAT Heart and brain
Pleven, Bulgaria
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, Bulgaria
UMHAT "Sv. Georgi", EAD
Plovdiv, Bulgaria
UMHAT Kanev AD
Rousse, Bulgaria
UMHAT "Medika Ruse" OOD
Rousse, Bulgaria
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Silven, Bulgaria
MHATNP "Sv. Naum" EAD
Sofia, Bulgaria
University First MHAT-Sofia "St. Joan Krastitel" EAD
Sofia, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, Bulgaria
Medical Military Academy MHAT Sofia
Sofia, Bulgaria
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, Bulgaria
University Hospital St. Anna
Sofia, Bulgaria
MHAT 'Sv. Anna - Varna' AD
Varna, Bulgaria
The People's Hospital of Anyang City
Anyang, China
Baoji Central Hospital
Baoji, China
Inner Mongolia Baogang Hospital
Baotou, China
Cap Med University
Beijing, China
Peking University Third Hospital
Beijing, China
Hebei Cangzhou Central Hospital
Cangzhou, China
Jilin Cancer Hospital
Changchun, China
Hunan Provincial People's Hospital
Changsha, China
Chengdu Second People's Hospital
Chengdu, China
Chifeng Traditional Chinese and Mongolian Medicine Hospital
Chifeng, China
Daqing Longnan Hospital
Daqing, China
Daqing Oilfield General Hospital
Daqing, China
The First People's Hospital of Foshan
Foshan, China
General Hospital of Fushun Mining Bureau
Fushun, China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Second Hospital of Harbin Medical University
Haerbin, China
The First Affiliated Hospital of University of South China
Hengyang, China
Huai'an Second People's Hospital
Huai'an, China
Huizhou Central People's Hospital
Huizhou, China
Huizhou First Hospital
Huizhou, China
Meihekou Central Hospital
Jilin City, China
Jinhua Municipal Central Hospital
Jinhua, China
Jining No.1 People's Hospital
Jining, China
Affiliated Hospital of Jiujiang University
Jiujiang, China
First People's Hospital of Yunnan Province
Kunming, China
Liaocheng People's Hospital
Liaocheng, China
Linfen Central Hospital
Linfen, China
Linyi People's Hospital
Linyi, China
Lu'an People's Hospital
Lu'an, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Luoyang Central Hospital
Luoyang, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Nanyang Central Hospital
Nanyang, China
Nanyang Nanshi Hospital
Nanyang, China
Ordos Central Hostipal
Ordos, China
Pingxiang People's Hospital
Pingxiang, China
Qingdao Central Hospital
Qingdao, China
Qingdao Municipal Hospital
Qingdao, China
Huashan Hospital, Fudan University
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
Shangrao People's Hospital
Shangrao, China
Yuebei People's Hospital
Shaoguan, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, China
The First People's Hospital of Shenyang
Shenyang, China
Hebei General Hospital
Shijiazhuang, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Shiyan Taihe Hospital
Shiyan, China
Sichuan Provincial People's Hospital
Sichuan, China
Shanxi Cardiovascular Hospital
Taiyuan, China
The First People's Hospital of Tancheng
Tengzhou, China
Weifang People's Hospital
Weifang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The Central Hospital of Wuhan
Wuhan, China
Wuhan Puai Hospital
Wuhan, China
Xinxiang Central Hospital
Xinxiang, China
The People's Hospital Of Xuancheng City
Xuancheng, China
Xuzhou Central Hospital
Xuzhou, China
Yantai Yuhuangding Hospital
Yantai, China