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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

Status: Recruiting
Location: See all (218) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

• Pre-stroke modified Rankin scale (mRS) ≤1

• Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)

Locations
Other Locations
Argentina
Sanatorio Güemes
NOT_YET_RECRUITING
Buenos Aires
CEMIC
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Clínica La Sagrada Familia
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Complejo Medico de la Policia Federal Argentina Churruca Visca
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Hospital General de Agudos Dr. J. M. Ramos Mejia
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Clinica Privada Velez Sarfield
NOT_YET_RECRUITING
Córdoba
Hospital Cordoba
NOT_YET_RECRUITING
Córdoba
Nuevo Hospital San Roque
NOT_YET_RECRUITING
Córdoba
Sanatorio Allende
NOT_YET_RECRUITING
Córdoba
Sanatorio de la Canada
NOT_YET_RECRUITING
Córdoba
Sanatorio Privado Duarte Quiros De Clinica Colombo SA
NOT_YET_RECRUITING
Córdoba
Hospital Privado de Comunidad
NOT_YET_RECRUITING
Mar Del Plata
Hospital Universitario Austral
NOT_YET_RECRUITING
Pilar
Hospital Privado de Rosario
NOT_YET_RECRUITING
Rosario
Australia
Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Eastern Health-Box Hill Hospital
RECRUITING
Box Hill
Campbelltown Hospital
NOT_YET_RECRUITING
Campbelltown
Monash Medical Centre
NOT_YET_RECRUITING
Clayton
Liverpool Hospital
NOT_YET_RECRUITING
Liverpool
John Hunter Hospital
NOT_YET_RECRUITING
New Lambton Heights
Royal Melbourne Hospital
NOT_YET_RECRUITING
Parkville
Bulgaria
MHAT Puls AD
NOT_YET_RECRUITING
Blagoevgrad
MHAT Heart and brain
NOT_YET_RECRUITING
Burgas
MHAT Sv. Ivan Rilski EOOD
NOT_YET_RECRUITING
Gorna Oryahovitsa
MHAT City Clinic Saint Georgi Ltd
NOT_YET_RECRUITING
Montana
MHAT Heart and brain
NOT_YET_RECRUITING
Pleven
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
NOT_YET_RECRUITING
Pleven
UMHAT Kaspela, EOOD
NOT_YET_RECRUITING
Plovdiv
UMHAT Sv. Georgi, EAD
NOT_YET_RECRUITING
Plovdiv
UMHAT Medika Ruse OOD
NOT_YET_RECRUITING
Rousse
MHAT Hadzhi Dimitar OOD
NOT_YET_RECRUITING
Silven
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
NOT_YET_RECRUITING
Sofia
MHATNP Sv. Naum EAD
NOT_YET_RECRUITING
Sofia
Multiprofile Hospital MHATEM 'Pirogov', Sofia
NOT_YET_RECRUITING
Sofia
University First MHAT-Sofia St. Joan Krastitel EAD
NOT_YET_RECRUITING
Sofia
University Hospital St. Anna
NOT_YET_RECRUITING
Sofia
China
The People's Hospital of Anyang City
NOT_YET_RECRUITING
Anyang
Baoji Central Hospital
NOT_YET_RECRUITING
Baoji
Inner Mongolia Baogang Hospital
NOT_YET_RECRUITING
Baotou
Cap Med University
RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
Hunan Province People's Hospital (The First Affiliated Hospital of Hunan Normal University)
NOT_YET_RECRUITING
Changsha
Chengdu Second People's Hospital
NOT_YET_RECRUITING
Chengdu
Chifeng Traditional Chinese and Mongolian Medicine Hospital
NOT_YET_RECRUITING
Chifeng
Daqing Longnan Hospital
NOT_YET_RECRUITING
Daqing
Daqing Oilfield General Hospital
NOT_YET_RECRUITING
Daqing
The First People's Hospital of Foshan
NOT_YET_RECRUITING
Foshan
General Hospital of Fushun Mining Bureau
NOT_YET_RECRUITING
Fushun
Third Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The Second Hospital of Harbin Medical University
NOT_YET_RECRUITING
Haerbin
The First Affiliated Hospital of University of South China
NOT_YET_RECRUITING
Hengyang
Meihekou Central Hospital
NOT_YET_RECRUITING
Jilin
Jinhua Municipal Central Hospital
NOT_YET_RECRUITING
Jinhua
Affiliated Hospital of Jiujiang University
NOT_YET_RECRUITING
Jiujiang
First People's hospital of Yunann Province
NOT_YET_RECRUITING
Kunming
Liaocheng People's Hospital
NOT_YET_RECRUITING
Liaocheng
Linfen Central Hospital
NOT_YET_RECRUITING
Linfen
Linyi People's Hospital
NOT_YET_RECRUITING
Linyi
Lu'an People's Hospital
NOT_YET_RECRUITING
Lu'an
The Second Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
The Second Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Nanyang Central Hospital
NOT_YET_RECRUITING
Nanyang
Pingxiang People's Hospital
NOT_YET_RECRUITING
Pingxiang
Qingdao Municipal Hospital
NOT_YET_RECRUITING
Qingdao
Huashan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
Shangrao People's Hospital
NOT_YET_RECRUITING
Shangrao
Affiliated Central Hospital of Shenyang Medical College
NOT_YET_RECRUITING
Shenyang
Shanxi Cardiovascular Hospital
NOT_YET_RECRUITING
Taiyuan
The First People's Hospital of Tancheng
NOT_YET_RECRUITING
Tengzhou
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
The Central Hospital of Wuhan
NOT_YET_RECRUITING
Wuhan
Wuhan Puai Hospital
NOT_YET_RECRUITING
Wuhan
Xinxiang Central Hospital
NOT_YET_RECRUITING
Xinxiang
The People's Hospital Of Xuancheng City
NOT_YET_RECRUITING
Xuancheng
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
Yulin First People's Hospital
NOT_YET_RECRUITING
Yulin
Zigong No. 1 People's Hospital
NOT_YET_RECRUITING
Zigong
Greece
University General Hospital of Alexandroupolis
NOT_YET_RECRUITING
Alexandroupoli
Athens Euroclinic S.A.
NOT_YET_RECRUITING
Athens
Athens Naval Hospital
NOT_YET_RECRUITING
Athens
Eginitio Hospital
NOT_YET_RECRUITING
Athens
University General Hospital Attikon
NOT_YET_RECRUITING
Athens
Metropolitan Hospital
NOT_YET_RECRUITING
Athens, Neo Faliro
University General Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion
University General Hospital of Larissa
NOT_YET_RECRUITING
Larissa
General University Hospital of Patras
NOT_YET_RECRUITING
Pátrai
General Hospital Of Thessaloniki Papageorgiou
NOT_YET_RECRUITING
Thessaloniki
University General Hospital of Thessaloniki AHEPA
NOT_YET_RECRUITING
Thessaloniki
Hungary
Budapesti Uzsoki Utcai Korhaz
NOT_YET_RECRUITING
Budapest
Semmelweis University
NOT_YET_RECRUITING
Budapest
Pest Megyei Flor Ferenc Hospital
NOT_YET_RECRUITING
Kistarcsa
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
NOT_YET_RECRUITING
Miskolc
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
NOT_YET_RECRUITING
Nyíregyháza
University of Pecs
NOT_YET_RECRUITING
Pécs
University of Szeged
NOT_YET_RECRUITING
Szeged
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
NOT_YET_RECRUITING
Székesfehérvár
India
Zydus Hospital - Ahmedabad
NOT_YET_RECRUITING
Ahmedabad
Bangalore Medical College
NOT_YET_RECRUITING
Bangalore
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
NOT_YET_RECRUITING
Belagavi
SUM Ultimate Medicare
NOT_YET_RECRUITING
Bhubaneswar
S.P. Medical College & Associated Group of Hospitals
NOT_YET_RECRUITING
Bikaner
Post Graduate Institute of Medical Education and Research
NOT_YET_RECRUITING
Chandigarh
K.G. Hospital and Post Graduate Medical Institute
NOT_YET_RECRUITING
Coimbatore
Max Super Speciality Hospital, Dehradun
NOT_YET_RECRUITING
Dehradun
Shri Mahant Indiresh Hospital
NOT_YET_RECRUITING
Dehradun
Max Super Speciality Hospital, Vaishali
NOT_YET_RECRUITING
Ghaziabad
Yashoda Medicity
NOT_YET_RECRUITING
Ghaziabad
Lalitha Super Speciality Hospital
NOT_YET_RECRUITING
Guntur
Karnataka Institute of Medical Sciences, Hubli
NOT_YET_RECRUITING
Hubli
Nizam's Institute of Medical Sciences
NOT_YET_RECRUITING
Hyderabad
Yashoda Hospitals, Somajiguda
NOT_YET_RECRUITING
Hyderabad
Renai Medicity Multi Super Specialty Hospital
NOT_YET_RECRUITING
Kochi
Bangur Institute of Neurosciences
NOT_YET_RECRUITING
Kolkata
Institute of Neurosciences Kolkata
NOT_YET_RECRUITING
Kolkata
Baby Memorial Hospital Kozhikode
NOT_YET_RECRUITING
Kozhikode
Christian Medical College, Ludhiana
NOT_YET_RECRUITING
Ludhiana
Chopda Medicare and Research Centre Pvt Ltd
NOT_YET_RECRUITING
Nashik
All India Institute of Medical Sciences, New Dehli
NOT_YET_RECRUITING
New Delhi
BLK-Max Super Speciality Hospital, Delhi
NOT_YET_RECRUITING
New Delhi
Max Super Speciality Hospital
NOT_YET_RECRUITING
New Delhi
Indira Gandhi Institute of Medical Sciences
NOT_YET_RECRUITING
Patna
Deenanath Mangeshkar Hospital and Research Centre
NOT_YET_RECRUITING
Pune
Great Eastern Medical School
NOT_YET_RECRUITING
Rāgolu
Synergy Superspeciality Hospital
NOT_YET_RECRUITING
Rajkot
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
NOT_YET_RECRUITING
Rohtak
Indira Gandhi Medical College & Hospital
NOT_YET_RECRUITING
Shimla
Unity Hospital
NOT_YET_RECRUITING
Surat
Bhaktivedanta Hospital & Research Institute
NOT_YET_RECRUITING
Thane
Sree Chitra Tirunal Institute for Medical Sciences & Technology
NOT_YET_RECRUITING
Thiruvananthapuram
City Neurology Centre
NOT_YET_RECRUITING
Varanasi
Christian Medical College, Vellore
NOT_YET_RECRUITING
Vellore
Government Siddhartha Medical College
NOT_YET_RECRUITING
Vijayawada
Visakha Institute of Medical Sciences
NOT_YET_RECRUITING
Visakhapatnam
Government Medical College Vizianagaram
NOT_YET_RECRUITING
Vizianagaram
Acharya Vinobha Bhave Rural Hospital
NOT_YET_RECRUITING
Wardha
Indonesia
Siloam Hospitals Denpasar
NOT_YET_RECRUITING
Badung
Immanuel Hospital Bandung
NOT_YET_RECRUITING
Bandung
Dr. Cipto Mangunkusumo Hospital
NOT_YET_RECRUITING
Jakarta
Mahar Mardjono National Brain Center Hospital
NOT_YET_RECRUITING
Jakarta
Siloam Hospitals Kebon Jeruk
NOT_YET_RECRUITING
Jakarta
Siloam Hospitals TB Simatupang
NOT_YET_RECRUITING
Jakarta
RSUP Dr. M. Djamil
NOT_YET_RECRUITING
Padang
RSUP Dr. Kariadi
NOT_YET_RECRUITING
Semarang
Airlangga University Hospital
NOT_YET_RECRUITING
Surabaya
Siloam Hospitals Lippo Village
NOT_YET_RECRUITING
Tangerang
Bethesda Hospital
NOT_YET_RECRUITING
Yogyakarta
RS Akademik UGM
NOT_YET_RECRUITING
Yogyakarta
Sardjito Hospital
NOT_YET_RECRUITING
Yogyakarta
Kazakhstan
City Multidisciplinary Hospital No 2
NOT_YET_RECRUITING
Astana
National Coordination Center for Emergency Medicine
NOT_YET_RECRUITING
Astana
Malaysia
Hospital Pengajar UiTM Puncak Alam
NOT_YET_RECRUITING
Bandar Puncak Alam
Hospital Raja Permaisuri Bainun
NOT_YET_RECRUITING
Ipoh
Hospital Raja Perempuan Zainab II
NOT_YET_RECRUITING
Kota Bharu
Hospital Universiti Sains Malaysia
NOT_YET_RECRUITING
Kota Bharu
Hospital Kuala Lumpur
NOT_YET_RECRUITING
Kuala Lumpur
Universiti Putra Malaysia
NOT_YET_RECRUITING
Serdang
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Sykehuset Ostfold HF
NOT_YET_RECRUITING
Grålum
Helse Stavanger, Stavanger Universitetssykehus
NOT_YET_RECRUITING
Stavanger
Romania
Spitalul Clinic Județean De Urgența Arad
NOT_YET_RECRUITING
Arad
Spitalul Clinic Judetean de Urgenta Brasov
NOT_YET_RECRUITING
Brasov
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
NOT_YET_RECRUITING
Constanța
Spitalul Judetean de Urgenta Piatra Neamt
NOT_YET_RECRUITING
Piatra Neamţ
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
NOT_YET_RECRUITING
Suceava
Spitalul Clinic Judetean de Urgenta Targu Mures
NOT_YET_RECRUITING
Târgu Mureş
Spain
Complejo Hospitalario Universitario A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital General Universitario Dr. Balmis
NOT_YET_RECRUITING
Alicante
Hospital Universitario de Cruces
NOT_YET_RECRUITING
Barakaldo
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Germans Trias i Pujol
NOT_YET_RECRUITING
Barcelona
Hospital Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron - VHIR
NOT_YET_RECRUITING
Barcelona
Hospital Universitari de Girona Doctor Josep Trueta
NOT_YET_RECRUITING
Girona
Hospital Universitari de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Ruber Juan Bravo
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario De La Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Universitario Virgen De La Macarena
NOT_YET_RECRUITING
Seville
Hospital Universitari Joan XXIII
NOT_YET_RECRUITING
Tarragona
Hospital Universitari Mutua de Terrasa
NOT_YET_RECRUITING
Terrassa
Hospital Clinico Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Álvaro Cunqueiro
NOT_YET_RECRUITING
Vigo
Hospital Clinico Universitario Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Taiwan
Chang Gung Memorial Hospital Chiayi
NOT_YET_RECRUITING
Buzi
Changhua Christian Hospital
NOT_YET_RECRUITING
Changhua
Chang Gung Memorial Hospital-Keelung
NOT_YET_RECRUITING
Keelung
Taipei Medical University-Shuang Ho Hospital
NOT_YET_RECRUITING
New Taipei City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Tri-Service General Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
NOT_YET_RECRUITING
Taoyuan
Thailand
King Chulalongkorn Memorial Hospital
NOT_YET_RECRUITING
Bangkok
Phramongkutklao Hospital
NOT_YET_RECRUITING
Bangkok
Ramathibodi Hospital
NOT_YET_RECRUITING
Bangkok
Siriraj Hospital
NOT_YET_RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital
NOT_YET_RECRUITING
Chiang Mai
Srinagarind Hospital
NOT_YET_RECRUITING
Khon Kaen
Thammasat University Hospital
NOT_YET_RECRUITING
Klong Luang
Lampang Hospital
NOT_YET_RECRUITING
Lampang
Sunprasitthiprasong Hospital
NOT_YET_RECRUITING
Muang
Viet Nam
Da Nang Hospital
NOT_YET_RECRUITING
Da Nang
Viet Tiep Hospital
NOT_YET_RECRUITING
Haiphong
Bach Mai hospital
NOT_YET_RECRUITING
Hanoi
Le Van Thinh Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
Military Hospital 175
NOT_YET_RECRUITING
Ho Chi Minh City
Nguyen Tri Phuong Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
Nhan Dan Gia Dinh Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
People's Hospital 115
NOT_YET_RECRUITING
Ho Chi Minh City
Thong Nhat Hospital HCMC
NOT_YET_RECRUITING
Ho Chi Minh City
University Medical Center HCMC
NOT_YET_RECRUITING
Ho Chi Minh City
Phu Tho General Hospital
NOT_YET_RECRUITING
Việt Trì
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2027-10-02
Participants
Target number of participants: 1325
Treatments
Experimental: Tenecteplase treatment arm
Active_comparator: Standard of care treatment arm
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov