Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Tenecteplase
Tenecteplase
Standard of care treatment
Standard of care treatment
Locations (197)
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
Clínica 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 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 "Medika Ruse" OOD
Rousse, Bulgaria
MHAT "Hadzhi 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
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, Bulgaria
University Hospital St. Anna
Sofia, 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
Jilin Cancer Hospital
Changchun, China
Hunan Province People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, China
Chifeng Traditional Chinese and Mongolian Medicine Hospital
Chifeng, 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
Meihekou Central Hospital
Jilin, China
Jinhua Municipal Central Hospital
Jinhua, China
First People's hospital of Yunann 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
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Nanyang Central Hospital
Nanyang, China
Pingxiang People's Hospital
Pingxiang, China
Qingdao Municipal Hospital
Qingdao, China
Huashan Hospital, Fudan University
Shanghai, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, China
Shanxi Cardiovascular Hospital
Taiyuan, China
The First People's Hospital of Tancheng
Tengzhou, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The Central Hospital of Wuhan
Wuhan, China
The People's Hospital Of Xuancheng City
Xuancheng, China
Xuzhou Central Hospital
Xuzhou, China
Yulin First People's Hospital
Yulin, China
Zigong No. 1 People's Hospital
Zigong, China
University General Hospital of Alexandroupolis
Alexandroupoli, Greece
Athens Euroclinic S.A.
Athens, Greece
Athens Naval Hospital
Athens, Greece
Eginitio Hospital
Athens, Greece
University General Hospital Attikon
Athens, Greece
Metropolitan Hospital
Athens, Neo Faliro, Greece
University General Hospital of Heraklion
Heraklion, Greece
General University Hospital of Larissa
Larissa, Greece
General University Hospital of Patras
Pátrai, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, Greece
Semmelweis University
Budapest, Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, Hungary
Pest Megyei Flor Ferenc Hospital
Kistarcsa, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary
University of Pecs
Pécs, Hungary
University of Szeged
Szeged, Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary
Zydus Hospital - Ahmedabad
Ahmedabad, India
Bangalore Medical College
Bangalore, India
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, India
S.P. Medical College & Associated Group of Hospitals
Bikaner, India
Post Graduate Institute of Medical Education and Research
Chandigarh, India
K.G. Hospital and Post Graduate Medical Institute
Coimbatore, India
Shri Mahant Indiresh Hospital
Dehradun, India
Max Super Speciality Hospital, Vaishali
Ghaziabad, India
Lalitha Super Speciality Hospital
Guntur, India
Nizam's Institute of Medical Sciences
Hyderabad, India
Yashoda Hospitals, Somajiguda
Hyderabad, India
Renai Medicity Multi Super Specialty Hospital
Kochi, India
Institute of Neurosciences Kolkata
Kolkata, India
Bangur Institute of Neurosciences
Kolkata, India
Christian Medical College, Ludhiana
Ludhiana, India
Chopda Medicare and Research Centre Pvt Ltd
Nashik, India
BLK-Max Super Speciality Hospital, Delhi
New Delhi, India
Max Super Speciality Hospital
New Delhi, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, India
Synergy Superspeciality Hospital
Rajkot, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, India
Indira Gandhi Medical College & Hospital
Shimla, India
Unity Hospital
Surat, India
Bhaktivedanta Hospital & Research Institute
Thane, India
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Thiruvananthapuram, India
City Neurology Centre
Varanasi, India
Christian Medical College, Vellore
Vellore, India
Government Siddhartha Medical College
Vijayawada, India
Visakha Institute of Medical Sciences
Visakhapatnam, India
Government Medical College Vizianagaram
Vizianagaram, India
Acharya Vinobha Bhave Rural Hospital
Wardha, India
Siloam Hospitals Denpasar
Badung, Indonesia
Immanuel Hospital Bandung
Bandung, Indonesia
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
Siloam Hospitals Kebon Jeruk
Jakarta, Indonesia
Siloam Hospitals TB Simatupang
Jakarta, Indonesia
Mahar Mardjono National Brain Center Hospital
Jakarta, Indonesia
Airlangga University Hospital
Surabaya, Indonesia
Siloam Hospitals Lippo Village
Tangerang, Indonesia
Bethesda Hospital
Yogyakarta, Indonesia
RS Akademik UGM
Yogyakarta, Indonesia
Sardjito Hospital
Yogyakarta, Indonesia
City Multidisciplinary Hospital No 2
Astana, Kazakhstan
National Coordination Center for Emergency Medicine
Astana, Kazakhstan
Hospital Pengajar UiTM Puncak Alam
Bandar Puncak Alam, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Universiti Putra Malaysia
Serdang, Malaysia
Haukeland University Hospital
Bergen, Norway
Sykehuset Ostfold HF
Grålum, Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, Norway
Spitalul Clinic Județean De Urgența Arad
Arad, Romania
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, Romania
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Romania
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Ruber Juan Bravo
Madrid, Spain
Hospital Universitario De La Princesa
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Hospital Universitari Mutua de Terrasa
Terrassa, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
Chang Gung Memorial Hospital Chiayi
Buzi, Taiwan
Chang Gung Memorial Hospital-Keelung
Keelung, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
Thammasat University Hospital
Klong Luang, Thailand
Lampang Hospital
Lampang, Thailand
Sunprasitthiprasong Hospital
Muang, Thailand
Da Nang Hospital
Da Nang, Vietnam
Viet Tiep Hospital
Haiphong, Vietnam
Bach Mai hospital
Hanoi, Vietnam
Le Van Thinh Hospital
Ho Chi Minh City, Vietnam
Military Hospital 175
Ho Chi Minh City, Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, Vietnam
Nhan Dan Gia Dinh Hospital
Ho Chi Minh City, Vietnam
People's Hospital 115
Ho Chi Minh City, Vietnam
Thong Nhat Hospital HCMC
Ho Chi Minh City, Vietnam
University Medical Center HCMC
Ho Chi Minh City, Vietnam
Phu Tho General Hospital
Việt Trì, Vietnam