RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07361302

Registry updated: 2026-10-13

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Description

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.

Interventions

Tenecteplase (Drug)
Tenecteplase
Standard of care treatment (Drug)
Standard of care treatment

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.

Conditions

Acute Ischemic Stroke

Locations

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
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
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
Yulin First People's Hospital — Yulin, China
Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, China
Zhengzhou Central Hospital — Zhengzhou, 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
General Hospital of Athens "Alexandra" — Athens, Greece
University General Hospital Attikon — Athens, Greece
Metropolitan Hospital — Athens, Neo Faliro, Greece
University General Hospital of Heraklion — Heraklion, Greece
University General Hospital of Larissa — Larissa, Greece
General University Hospital of Patras — Pátrai, Greece
University General Hospital of Thessaloniki AHEPA — Thessaloniki, Greece
Hippokration General Hospital of Athen — 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
SUM Ultimate Medicare — Bhubaneswar, India
S.P. Medical College & Associated Group of Hospitals — Bikaner, India
Malabar Institute of Medical Sciences Ltd. — Calicut, India
Post Graduate Institute of Medical Education and Research — Chandigarh, India
K.G. Hospital and Post Graduate Medical Institute — Coimbatore, India
North Bengal Medical College and Hospital — Darjeeling, India
Max Super Speciality Hospital, Dehradun — Dehradun, India
Shri Mahant Indiresh Hospital — Dehradun, India
GGS Medical College & Hospital — Farīdkot, India
Max Super Speciality Hospital, Vaishali — Ghaziabad, India
Yashoda Medicity — Ghaziabad, India
Government General Hospital Guntur — Guntur, India
Lalitha PVS Institute of Medical Sciences — Guntur, India
Lalitha Super Speciality Hospital — Guntur, India
Karnataka Institute of Medical Sciences, Hubli — Hubli, India
Glenfield Mallareddy Brain Heart Hospital — Hyderabad, India
Renova Century Hospital - Banjara Hills — Hyderabad, India
Nizam's Institute of Medical Sciences — Hyderabad, India
Yashoda Hospitals, Somajiguda — Hyderabad, India
Government Medical College Jammu — Jammu, India
Renai Medicity Multi Super Specialty Hospital — Kochi, India
Institute of Neurosciences Kolkata — Kolkata, India
Bangur Institute of Neurosciences — Kolkata, India
Baby Memorial Hospital Kozhikode — Kozhikode, India
Christian Medical College, Ludhiana — Ludhiana, India
Chopda Medicare and Research Centre Pvt Ltd — Nashik, India
Sahyadri Superspeciality Hospital, Nashik — Nashik, India
Vijaya Super Speciality Hospital — Nellore, India
BLK-Max Super Speciality Hospital, Delhi — New Delhi, India
Max Super Speciality Hospital — New Delhi, India
All India Institute of Medical Sciences, New Dehli — New Delhi, India
Dr. Ram Manohar Lohia Hospital — New Delhi, India
Government Medical College, Ongole — Ongole, India
Indira Gandhi Institute of Medical Sciences — Patna, India
Deenanath Mangeshkar Hospital and Research Centre — Pune, India
Synergy Superspeciality Hospital — Rajkot, India
Great Eastern Medical School — Rāgolu, 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
Siloam Hospitals Medan — Medan, Indonesia
RSUP Dr. M. Djamil — Padang, Indonesia
RSUP Dr. Kariadi — Semarang, 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 Raja Perempuan Zainab II — 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 de Salamanca — Salamanca, Spain
Hospital Universitario Virgen De La Macarena — Seville, Spain
Hospital Universitari Joan XXIII — Tarragona, Spain
Hospital Universitari Mutua de Terrasa — Terrassa, Spain
Hospital Clinico Universitario de Valencia — Valencia, Spain
Hospital Álvaro Cunqueiro — Vigo, Spain
Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain
Chang Gung Memorial Hospital Chiayi — Buzi, Taiwan
Changhua Christian Hospital — Changhua, 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 City, 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 — Viet Tri, Vietnam

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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