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)

October 26, 2026 updated by: Boehringer Ingelheim

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1325

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1180AAX
      • Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
        • Not yet recruiting
        • Hospital General de Agudos Dr. J. M. Ramos Mejia
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1437JCP
        • Not yet recruiting
        • Complejo Medico de la Policia Federal Argentina Churruca Visca
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, 1199
        • Not yet recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, 1431
      • Ciudad Autonoma Buenos Aires, Argentina, C1426EOB
      • Ciudad Autonoma Buenos Aires, Argentina, C1428AQK
        • Not yet recruiting
        • Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
        • Contact:
      • Córdoba, Argentina, 5000
      • Córdoba, Argentina, X5000BSQ
      • Córdoba, Argentina, X5004CDT
      • Córdoba, Argentina, 5000
      • Córdoba, Argentina, 5000
      • Córdoba, Argentina, 5000
        • Recruiting
        • Sanatorio Privado Duarte Quiros De Clinica Colombo SA
        • Contact:
      • Mar del Plata, Argentina, B7602CBM
        • Not yet recruiting
        • Hospital Privado de Comunidad
        • Contact:
      • Pilar, Argentina, B1629ODT
      • Rosario, Argentina, S2000GAP
  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
      • Liverpool, New South Wales, Australia, 2170
      • New Lambton Heights, New South Wales, Australia, 2305
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Clayton, Victoria, Australia, 3168
      • Parkville, Victoria, Australia, 3050
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
      • Blagoevgrad, Bulgaria, 2700
      • Burgas, Bulgaria, 8000
      • Gorna Oryahovitsa, Bulgaria, 5100
      • Montana, Bulgaria, 3400
      • Pleven, Bulgaria, 5803
        • Recruiting
        • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
        • Contact:
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4002
      • Plovdiv, Bulgaria, 4000
      • Rousse, Bulgaria, 7013
      • Rousse, Bulgaria, 7000
      • Silven, Bulgaria, 8800
        • Recruiting
        • Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
        • Contact:
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Multiprofile Hospital MHATEM 'Pirogov', Sofia
        • Contact:
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic Tokuda University Hospital EAD
        • Contact:
      • Sofia, Bulgaria, 1113
      • Sofia, Bulgaria, 1142
        • Recruiting
        • University First MHAT-Sofia "St. Joan Krastitel" EAD
        • Contact:
      • Sofia, Bulgaria, 1750
      • Varna, Bulgaria, 9002
  • China
      • Anyang, China, 455002
        • Recruiting
        • The People's Hospital of Anyang City
        • Contact:
      • Baoji, China, 721008
        • Recruiting
        • Baoji Central Hospital
        • Contact:
      • Baotou, China, 14010
        • Recruiting
        • Inner Mongolia Baogang Hospital
        • Contact:
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100069
      • Cangzhou, China, 61001
        • Recruiting
        • Hebei Cangzhou Central Hospital
        • Contact:
      • Changchun, China, 130000
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Changsha, China, 410005
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Chengdu, China, 610021
        • Recruiting
        • Chengdu Second People's Hospital
        • Contact:
      • Chifeng, China, 24005
        • Recruiting
        • Chifeng Traditional Chinese and Mongolian Medicine Hospital
        • Contact:
      • Daqing, China, 163001
        • Recruiting
        • Daqing Oilfield General Hospital
        • Contact:
      • Daqing, China, 163000
        • Recruiting
        • Daqing Longnan Hospital
        • Contact:
      • Foshan, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Fushun, China, 113008
        • Recruiting
        • General Hospital of Fushun Mining Bureau
        • Contact:
      • Guangzhou, China, 510150
        • Recruiting
        • Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Haerbin, China, 150086
        • Not yet recruiting
        • The Second Hospital of Harbin Medical University
        • Contact:
      • Hengyang, China, 421001
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
      • Huai'an, China, 223002
        • Recruiting
        • Huai'an Second People's Hospital
        • Contact:
      • Huizhou, China, 516003
        • Recruiting
        • Huizhou First Hospital
        • Contact:
      • Huizhou, China, 516001
        • Not yet recruiting
        • Huizhou Central People's Hospital
        • Contact:
      • Jilin City, China, 135000
        • Recruiting
        • Meihekou Central Hospital
        • Contact:
      • Jinhua, China, 321000
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
      • Jining, China, 272011
        • Recruiting
        • Jining No.1 People's Hospital
        • Contact:
      • Jiujiang, China, 332000
        • Not yet recruiting
        • Affiliated Hospital of Jiujiang University
        • Contact:
      • Kunming, China, 650032
        • Recruiting
        • First People's Hospital of Yunnan Province
        • Contact:
      • Liaocheng, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Linfen, China, 041000
        • Recruiting
        • Linfen Central Hospital
        • Contact:
      • Linyi, China, 276005
        • Recruiting
        • Linyi People's Hospital
        • Contact:
      • Lu'an, China, 237005
        • Not yet recruiting
        • Lu'an People's Hospital
        • Contact:
      • Luoyang, China, 471009
        • Not yet recruiting
        • Luoyang Central Hospital
        • Contact:
      • Luoyang, China, 471000
        • Recruiting
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanjing, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanyang, China, 473000
        • Recruiting
        • Nanyang Central Hospital
        • Contact:
      • Nanyang, China, 473001
        • Recruiting
        • Nanyang Nanshi Hospital
        • Contact:
      • Ordos, China, 017000
        • Not yet recruiting
        • Ordos Central Hostipal
        • Contact:
      • Pingxiang, China, 337055
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
      • Qingdao, China, 266071
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Qingdao, China, 266024
        • Recruiting
        • Qingdao Central Hospital
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 200072
        • Not yet recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
      • Shangrao, China, 334000
        • Recruiting
        • Shangrao People's Hospital
        • Contact:
      • Shaoguan, China, 512026
        • Recruiting
        • Yuebei People's Hospital
        • Contact:
      • Shenyang, China, 110000
        • Recruiting
        • Affiliated Central Hospital of Shenyang Medical College
        • Contact:
      • Shenyang, China, 110000
        • Recruiting
        • The First People's Hospital of Shenyang
        • Contact:
      • Shijiazhuang, China, 500051
        • Recruiting
        • Hebei General Hospital
        • Contact:
      • Shijiazhuang, China, 50066
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Shiyan, China, 442000
        • Not yet recruiting
        • Shiyan Taihe Hospital
        • Contact:
      • Sichuan, China, 610031
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Taiyuan, China, 30013
        • Recruiting
        • Shanxi Cardiovascular Hospital
        • Contact:
      • Tengzhou, China, 276199
        • Recruiting
        • The First People's Hospital of Tancheng
        • Contact:
      • Weifang, China, 261000
        • Not yet recruiting
        • Weifang People's Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430014
        • Recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Wuhan, China, 430033
      • Xinxiang, China, 453000
        • Recruiting
        • Xinxiang Central Hospital
        • Contact:
      • Xuancheng, China, 242000
        • Recruiting
        • The People's Hospital Of Xuancheng City
        • Contact:
      • Xuzhou, China, 221009
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
      • Yantai, China, 264000
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
      • Yulin, China, 537000
        • Recruiting
        • Yulin First People's Hospital
        • Contact:
      • Zhangzhou, China, 363000
        • Recruiting
        • Zhangzhou Municipal Hospital of Fujian Province
        • Contact:
      • Zhengzhou, China, 450007
        • Not yet recruiting
        • Zhengzhou Central Hospital
        • Contact:
      • Zigong, China, 643000
        • Recruiting
        • Zigong No. 1 People's Hospital
        • Contact:
  • Greece
      • Alexandroupoli, Greece, 681 00
        • Not yet recruiting
        • University General Hospital of Alexandroupolis
        • Contact:
      • Athens, Greece, 11528
        • Not yet recruiting
        • General Hospital of Athens "Alexandra"
        • Contact:
      • Athens, Greece, 12462
        • Recruiting
        • University General Hospital Attikon
        • Contact:
      • Athens, Greece, 11528
      • Athens, Greece, 115 21
        • Not yet recruiting
        • Athens Euroclinic S.A.
        • Contact:
      • Athens, Greece, 115 21
      • Athens, Neo Faliro, Greece, 185 47
        • Not yet recruiting
        • Metropolitan Hospital
        • Contact:
      • Heraklion, Greece, 715 00
        • Not yet recruiting
        • University General Hospital of Heraklion
        • Contact:
      • Larissa, Greece, 411 10
        • Not yet recruiting
        • University General Hospital of Larissa
        • Contact:
      • Pátrai, Greece, 265 04
        • Recruiting
        • General University Hospital of Patras
        • Contact:
      • Thessaloniki, Greece, 564 29
        • Not yet recruiting
        • General Hospital Of Thessaloniki Papageorgiou
        • Contact:
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • University General Hospital of Thessaloniki AHEPA
        • Contact:
      • Thessaloniki, Greece, 546 42
        • Not yet recruiting
        • Hippokration General Hospital of Athen
        • Contact:
  • Hungary
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1145
      • Kistarcsa, Hungary, 2143
      • Miskolc, Hungary, 3526
        • Recruiting
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
        • Contact:
      • Nyíregyháza, Hungary, 4400
      • Pécs, Hungary, 7623
      • Szeged, Hungary, 6725
      • Székesfehérvár, Hungary, 8000
        • Recruiting
        • Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
        • Contact:
  • India
      • Ahmedabad, India, 380054
        • Recruiting
        • Zydus Hospital - Ahmedabad
        • Contact:
      • Bangalore, India, 560002
        • Recruiting
        • Bangalore Medical College
        • Contact:
      • Belagavi, India, 590010
        • Recruiting
        • KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
        • Contact:
      • Bhubaneswar, India, 751003
        • Recruiting
        • SUM Ultimate Medicare
        • Contact:
      • Bikaner, India, 334 003
        • Recruiting
        • S.P. Medical College & Associated Group of Hospitals
        • Contact:
      • Calicut, India, 673016
        • Recruiting
        • Malabar Institute of Medical Sciences Ltd.
        • Contact:
      • Chandigarh, India, 160012
        • Not yet recruiting
        • Post Graduate Institute of Medical Education and Research
        • Contact:
      • Coimbatore, India, 641018
        • Recruiting
        • K.G. Hospital and Post Graduate Medical Institute
        • Contact:
      • Darjeeling, India, 734 012
        • Not yet recruiting
        • North Bengal Medical College and Hospital
        • Contact:
      • Dehradun, India, 248001
        • Recruiting
        • Shri Mahant Indiresh Hospital
        • Contact:
      • Dehradun, India, 248001
        • Recruiting
        • Max Super Speciality Hospital, Dehradun
        • Contact:
      • Farīdkot, India, 151203
        • Not yet recruiting
        • GGS Medical College & Hospital
        • Contact:
      • Ghaziabad, India, 201014
        • Not yet recruiting
        • Yashoda Medicity
        • Contact:
      • Ghaziabad, India, 201012
        • Recruiting
        • Max Super Speciality Hospital, Vaishali
        • Contact:
      • Guntur, India, 522001
        • Not yet recruiting
        • Lalitha Super Speciality Hospital
        • Contact:
      • Guntur, India, 522001
        • Recruiting
        • Government General Hospital Guntur
        • Contact:
      • Guntur, India, 522001
        • Recruiting
        • Lalitha PVS Institute of Medical Sciences
        • Contact:
      • Hubli, India, 580021
        • Recruiting
        • Karnataka Institute of Medical Sciences, Hubli
        • Contact:
      • Hyderabad, India, 500082
        • Recruiting
        • Nizam's Institute of Medical Sciences
        • Contact:
      • Hyderabad, India, 500001
        • Recruiting
        • Glenfield Mallareddy Brain Heart Hospital
        • Contact:
      • Hyderabad, India, 500082
        • Recruiting
        • Yashoda Hospitals, Somajiguda
        • Contact:
      • Hyderabad, India, 500028
        • Recruiting
        • Renova Century Hospital - Banjara Hills
        • Contact:
      • Jammu, India, 180016
        • Not yet recruiting
        • Government Medical College Jammu
        • Contact:
      • Kochi, India, 682 025
        • Recruiting
        • Renai Medicity Multi Super Specialty Hospital
        • Contact:
      • Kolkata, India, 700017
        • Recruiting
        • Institute of Neurosciences Kolkata
        • Contact:
      • Kolkata, India, 700025
        • Recruiting
        • Bangur Institute of Neurosciences
        • Contact:
      • Kozhikode, India, 673004
        • Recruiting
        • Baby Memorial Hospital Kozhikode
        • Contact:
      • Ludhiana, India, 141008
        • Recruiting
        • Christian Medical College, Ludhiana
        • Contact:
      • Nashik, India, 422005
        • Recruiting
        • Chopda Medicare and Research Centre Pvt Ltd
        • Contact:
      • Nashik, India, 422011
        • Recruiting
        • Sahyadri Superspeciality Hospital, Nashik
        • Contact:
      • Nellore, India, 524001
        • Recruiting
        • Vijaya Super Speciality Hospital
        • Contact:
      • New Delhi, India, 110017
        • Recruiting
        • Max Super Speciality Hospital
        • Contact:
      • New Delhi, India, 1100o1
        • Not yet recruiting
        • Dr. Ram Manohar Lohia Hospital
        • Contact:
      • New Delhi, India, 110005
        • Recruiting
        • BLK-Max Super Speciality Hospital, Delhi
        • Contact:
      • New Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences, New Dehli
        • Contact:
      • Ongole, India, 523001
        • Recruiting
        • Government Medical College, Ongole
        • Contact:
      • Patna, India, 800014
        • Recruiting
        • Indira Gandhi Institute of Medical Sciences
        • Contact:
      • Pune, India, 411004
        • Recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
        • Contact:
      • Rajkot, India, 360005
        • Not yet recruiting
        • Synergy Superspeciality Hospital
        • Contact:
      • Rohtak, India, 124001
        • Recruiting
        • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
        • Contact:
      • Rāgolu, India, 532484
        • Recruiting
        • Great Eastern Medical School
        • Contact:
      • Shimla, India, 171001
        • Recruiting
        • Indira Gandhi Medical College & Hospital
        • Contact:
      • Surat, India, 395010
      • Thane, India, 401107
        • Not yet recruiting
        • Bhaktivedanta Hospital & Research Institute
        • Contact:
      • Thiruvananthapuram, India, 695011
        • Recruiting
        • Sree Chitra Tirunal Institute for Medical Sciences & Technology
        • Contact:
      • Varanasi, India, 221002
        • Recruiting
        • City Neurology Centre
        • Contact:
      • Vellore, India, 632004
        • Recruiting
        • Christian Medical College, Vellore
        • Contact:
      • Vijayawada, India, 520008
        • Recruiting
        • Government Siddhartha Medical College
        • Contact:
      • Visakhapatnam, India, 530040
        • Recruiting
        • Visakha Institute of Medical Sciences
        • Contact:
      • Vizianagaram, India, 535002
        • Recruiting
        • Government Medical College Vizianagaram
        • Contact:
      • Wardha, India, 442004
        • Not yet recruiting
        • Acharya Vinobha Bhave Rural Hospital
        • Contact:
  • Indonesia
      • Badung, Indonesia, 80361
        • Recruiting
        • Siloam Hospitals Denpasar
        • Contact:
      • Bandung, Indonesia, 40233
        • Not yet recruiting
        • Immanuel Hospital Bandung
        • Contact:
      • Jakarta, Indonesia, 12430
        • Recruiting
        • Siloam Hospitals TB Simatupang
        • Contact:
      • Jakarta, Indonesia, 13630
        • Recruiting
        • Mahar Mardjono National Brain Center Hospital
        • Contact:
      • Jakarta, Indonesia, 11530
        • Recruiting
        • Siloam Hospitals Kebon Jeruk
        • Contact:
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Dr. Cipto Mangunkusumo Hospital
        • Contact:
      • Medan, Indonesia, 20212
      • Padang, Indonesia, 25171
      • Semarang, Indonesia, 50231
      • Surabaya, Indonesia, 60115
        • Recruiting
        • Airlangga University Hospital
        • Contact:
      • Tangerang, Indonesia, 15811
        • Recruiting
        • Siloam Hospitals Lippo Village
        • Contact:
      • Yogyakarta, Indonesia, 55223
      • Yogyakarta, Indonesia, 55291
      • Yogyakarta, Indonesia
  • Kazakhstan
      • Astana, Kazakhstan, 10000
        • Not yet recruiting
        • City Multidisciplinary Hospital No 2
        • Contact:
      • Astana, Kazakhstan, 10000
        • Not yet recruiting
        • National Coordination Center for Emergency Medicine
        • Contact:
  • Malaysia
      • Bandar Puncak Alam, Malaysia, 43000
        • Not yet recruiting
        • Hospital Pengajar UiTM Puncak Alam
        • Contact:
      • Ipoh, Malaysia, 30450
        • Not yet recruiting
        • Hospital Raja Permaisuri Bainun
        • Contact:
      • Kota Bharu, Malaysia, 15586
        • Recruiting
        • Hospital Raja Perempuan Zainab II
        • Contact:
      • Kota Bharu, Malaysia, 15200
        • Recruiting
        • Hospital Universiti Sains Malaysia
        • Contact:
      • Kuala Lumpur, Malaysia, 50586
      • Serdang, Malaysia, 43400
  • Norway
      • Bergen, Norway, 5021
        • Not yet recruiting
        • Haukeland University Hospital
        • Contact:
      • Grålum, Norway, 1714
      • Stavanger, Norway, 4011
        • Not yet recruiting
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
  • Romania
      • Arad, Romania, 310037
        • Recruiting
        • Spitalul Clinic Județean De Urgența Arad
        • Contact:
      • Brasov, Romania, 500326
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta Brasov
        • Contact:
      • Constanța, Romania, 900591
        • Not yet recruiting
        • Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
        • Contact:
      • Piatra Neamţ, Romania, 610136
        • Recruiting
        • Spitalul Judetean de Urgenta Piatra Neamt
        • Contact:
      • Suceava, Romania, 720284
        • Recruiting
        • Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
        • Contact:
      • Târgu Mureş, Romania, 540136
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta Targu Mures
        • Contact:
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
      • Alicante, Spain, 03010
        • Not yet recruiting
        • Hospital General Universitario Dr. Balmis
        • Contact:
      • Barakaldo, Spain, 48903
        • Not yet recruiting
        • Hospital Universitario de Cruces
        • Contact:
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron - VHIR
        • Contact:
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Ruber Juan Bravo
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico San Carlos
        • Contact:
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital Universitario De La Princesa
        • Contact:
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Hospital Universitario de Salamanca
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
      • Tarragona, Spain, 43005
        • Not yet recruiting
        • Hospital Universitari Joan XXIII
        • Contact:
      • Terrassa, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua de Terrasa
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
      • Vigo, Spain, 36312
        • Not yet recruiting
        • Hospital Álvaro Cunqueiro
        • Contact:
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
  • Taiwan
      • Buzi, Taiwan, 61363
        • Recruiting
        • Chang Gung Memorial Hospital Chiayi
        • Contact:
      • Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
      • Keelung, Taiwan, 204
        • Recruiting
        • Chang Gung Memorial Hospital-Keelung
        • Contact:
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
      • Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Contact:
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Siriraj Hospital
        • Contact:
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Ramathibodi Hospital
        • Contact:
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Contact:
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Srinagarind Hospital
        • Contact:
      • Klong Luang, Thailand, 12120
        • Recruiting
        • Thammasat University Hospital
        • Contact:
      • Lampang, Thailand, 52000
        • Recruiting
        • Lampang Hospital
        • Contact:
      • Muang, Thailand, 34000
        • Recruiting
        • Sunprasitthiprasong Hospital
        • Contact:
  • Vietnam
      • Da Nang, Vietnam, 550000
      • Haiphong, Vietnam
      • Hanoi, Vietnam, 100000
      • Ho Chi Minh City, Vietnam, 700000
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Nguyen Tri Phuong Hospital
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Military Hospital 175
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • People's Hospital 115
        • Contact:
      • Ho Chi Minh City, Vietnam, 748806
        • Recruiting
        • University Medical Center HCMC
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
      • Viet Tri, Vietnam, 290000
        • Not yet recruiting
        • Phu Tho General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenecteplase treatment arm
Drug: Tenecteplase

Tenecteplase
Active Comparator: Standard of care treatment arm
Drug: Standard of care treatment

Standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS) score of 0-1 at Day 90
Time Frame: at day 90

The Modified Rankin Scale, MRS, is a tool used to evaluate disability after a stroke. The score ranges from 0 to 6, with higher values indicating greater severity of the disability.
at day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS (ordinal) at Day 90
Time Frame: at day 90
at day 90
mRS 0-2 at Day 90
Time Frame: at Day 90
at Day 90
Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h
Time Frame: after 36 hours
after 36 hours
sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h
Time Frame: after 36 hours
after 36 hours
Death from any cause within 90 days
Time Frame: up to 90 days
up to 90 days
Early neurological improvement (reduction in acute - 24-hour National Institute of Health Stroke Scale (NIHSS) score of ≥8 or value of 0/1)
Time Frame: at baseline/randomisation, 24 hours after randomization

NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items. The score ranges from 0 to a maximum of 42. For each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
at baseline/randomisation, 24 hours after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2026

Primary Completion (Estimated)

October 2, 2027

Study Completion (Estimated)

October 2, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

October 27, 2026

Last Update Submitted That Met QC Criteria

October 26, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1123-0060
  • 2025-522542-40-00 (Ctis)
  • U1111-1323-6001 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))
  • 2025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe