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)

May 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, 1431
      • Ciudad Autonoma Buenos Aires, Argentina, 1199
        • Not yet recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
        • Not yet recruiting
        • Hospital General de Agudos Dr. J. M. Ramos Mejia
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1428AQK
        • Not yet recruiting
        • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
        • 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, C1426EOB
      • Córdoba, Argentina, 5000
      • Córdoba, Argentina, 5000
      • Córdoba, Argentina, X5000BSQ
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Clinica Privada Velez Sarfield
        • Contact:
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Sanatorio Privado Duarte Quiros De Clinica Colombo SA
        • Contact:
      • Córdoba, Argentina, X5004CDT
      • Mar del Plata, Argentina, B7602CBM
        • Not yet recruiting
        • Hospital Privado de Comunidad
        • Contact:
      • Pilar, Argentina, B1629ODT
        • Not yet recruiting
        • Hospital Universitario Austral
        • Contact:
      • Rosario, Argentina, S2000GAP
        • Not yet recruiting
        • Hospital Privado de Rosario
        • Contact:
  • 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
      • Burgas, Bulgaria, 8000
      • Gorna Oryahovitsa, Bulgaria, 5100
      • Montana, Bulgaria, 3400
        • Not yet recruiting
        • MHAT City Clinic Saint Georgi Ltd
        • Contact:
      • Pleven, Bulgaria, 5800
      • Pleven, Bulgaria, 5803
        • Not yet recruiting
        • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
        • Contact:
      • Plovdiv, Bulgaria, 4002
      • Plovdiv, Bulgaria, 4000
      • Rousse, Bulgaria, 7013
      • Silven, Bulgaria, 8800
      • Sofia, Bulgaria, 1407
        • Not yet recruiting
        • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
        • Contact:
      • Sofia, Bulgaria, 1606
        • Not yet recruiting
        • Multiprofile Hospital MHATEM 'Pirogov', Sofia
        • Contact:
      • Sofia, Bulgaria, 1113
      • Sofia, Bulgaria, 1142
        • Not yet recruiting
        • University First MHAT-Sofia "St. Joan Krastitel" EAD
        • Contact:
      • Sofia, Bulgaria, 1750
  • China
      • Anyang, China, 455002
        • Not yet recruiting
        • The People's Hospital of Anyang City
        • Contact:
      • Baoji, China, 721008
        • Not yet recruiting
        • Baoji Central Hospital
        • Contact:
      • Baotou, China, 14010
        • Not yet recruiting
        • Inner Mongolia Baogang Hospital
        • Contact:
      • Beijing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100069
      • Changchun, China, 130000
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Changsha, China, 410005
        • Not yet recruiting
        • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
        • Contact:
      • Chengdu, China, 610021
        • Not yet recruiting
        • Chengdu Second People's Hospital
        • Contact:
      • Chifeng, China, 24005
        • Not yet recruiting
        • Chifeng Traditional Chinese and Mongolian Medicine Hospital
        • Contact:
      • Daqing, China, 163001
        • Not yet recruiting
        • Daqing Oilfield General Hospital
        • Contact:
      • Daqing, China, 163000
        • Not yet recruiting
        • Daqing Longnan Hospital
        • Contact:
      • Foshan, China, 528000
        • Not yet recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Fushun, China, 113008
        • Not yet recruiting
        • General Hospital of Fushun Mining Bureau
        • Contact:
      • Guangzhou, China, 510150
        • Not yet 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
        • Not yet recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
      • Jilin, China, 135000
        • Not yet recruiting
        • Meihekou Central Hospital
        • Contact:
      • Jinhua, China, 321000
        • Not yet recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
      • Jiujiang, China, 332000
        • Not yet recruiting
        • Affiliated Hospital of Jiujiang University
        • Contact:
      • Kunming, China, 650032
        • Not yet recruiting
        • First People's hospital of Yunann Province
        • Contact:
      • Liaocheng, China, 252000
        • Not yet recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Linfen, China, 041000
        • Not yet recruiting
        • Linfen Central Hospital
        • Contact:
      • Linyi, China, 276005
        • Not yet recruiting
        • Linyi People's Hospital
        • Contact:
      • Lu'an, China, 237005
        • Not yet recruiting
        • Lu'an People's Hospital
        • Contact:
      • Luoyang, China, 471000
        • Not yet recruiting
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanjing, China, 210011
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanyang, China, 473000
        • Not yet recruiting
        • Nanyang Central Hospital
        • Contact:
      • Pingxiang, China, 337055
        • Not yet recruiting
        • Pingxiang People's Hospital
        • Contact:
      • Qingdao, China, 266011
        • Not yet recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Shanghai, China, 200040
        • Not yet recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Shangrao, China, 334000
        • Not yet recruiting
        • Shangrao People's Hospital
        • Contact:
      • Shenyang, China, 110000
        • Not yet recruiting
        • Affiliated Central Hospital of Shenyang Medical College
        • Contact:
      • Taiyuan, China, 30013
        • Not yet recruiting
        • Shanxi Cardiovascular Hospital
        • Contact:
      • Tengzhou, China, 276199
        • Not yet recruiting
        • The First People's Hospital of Tancheng
        • Contact:
      • Wenzhou, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430014
        • Not yet recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Wuhan, China, 430033
        • Not yet recruiting
        • Wuhan Puai Hospital
        • Contact:
      • Xinxiang, China, 453000
        • Not yet recruiting
        • Xinxiang Central Hospital
        • Contact:
      • Xuancheng, China, 242000
        • Not yet recruiting
        • The People's Hospital Of Xuancheng City
        • Contact:
      • Xuzhou, China, 221009
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
      • Yantai, China, 264000
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
      • Yulin, China, 537000
        • Not yet recruiting
        • Yulin First People's Hospital
        • Contact:
      • Zigong, China, 643000
        • Not yet 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
        • Eginitio Hospital
        • Contact:
      • Athens, Greece, 12462
        • Not yet recruiting
        • University General Hospital Attikon
        • Contact:
      • Athens, Greece, 115 21
        • Not yet recruiting
        • Athens Euroclinic S.A.
        • Contact:
      • Athens, Greece, 115 21
        • Not yet recruiting
        • Athens Naval Hospital
        • Contact:
      • 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
        • Not yet recruiting
        • General University Hospital of Patras
        • Contact:
      • Thessaloniki, Greece, 546 36
        • Not yet recruiting
        • University General Hospital of Thessaloniki AHEPA
        • Contact:
      • Thessaloniki, Greece, 564 29
        • Not yet recruiting
        • General Hospital Of Thessaloniki Papageorgiou
        • Contact:
  • Hungary
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1145
      • Kistarcsa, Hungary, 2143
      • Miskolc, Hungary, 3526
        • Not yet recruiting
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
        • Contact:
      • Nyíregyháza, Hungary, 4400
        • Not yet recruiting
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
        • Contact:
      • Pécs, Hungary, 7623
      • Szeged, Hungary, 6725
      • Székesfehérvár, Hungary, 8000
        • Not yet recruiting
        • Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
        • Contact:
  • India
      • Ahmedabad, India, 380054
        • Not yet recruiting
        • Zydus Hospital - Ahmedabad
        • Contact:
      • Bangalore, India, 560002
        • Not yet recruiting
        • Bangalore Medical college
        • Contact:
      • Belagavi, India, 590010
        • Not yet recruiting
        • KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
        • Contact:
      • Bhubaneswar, India, 751003
        • Not yet recruiting
        • SUM Ultimate Medicare
        • Contact:
      • Bikaner, India, 334 003
        • Not yet recruiting
        • S.P. Medical College & Associated Group of Hospitals
        • Contact:
      • Calicut, India, 673016
        • Not yet 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
        • Not yet 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
        • Not yet recruiting
        • Shri Mahant Indiresh Hospital
        • Contact:
      • Dehradun, India, 248001
        • Not yet recruiting
        • Max Super Speciality Hospital, Dehradun
        • Contact:
      • Farīdkot, India, 151203
        • Not yet recruiting
        • GGS Medical College & Hospital
        • Contact:
      • Ghaziabad, India, 201012
        • Not yet recruiting
        • Max Super Speciality Hospital, Vaishali
        • Contact:
      • Ghaziabad, India, 201014
        • Not yet recruiting
        • Yashoda Medicity
        • Contact:
      • Guntur, India, 522001
        • Not yet recruiting
        • Lalitha Super Speciality Hospital
        • Contact:
      • Guntur, India, 522001
        • Not yet recruiting
        • Government General Hospital Guntur
        • Contact:
      • Hubli, India, 580021
        • Not yet recruiting
        • Karnataka Institute of Medical Sciences, Hubli
        • Contact:
      • Hyderabad, India, 500082
        • Not yet recruiting
        • Nizam's Institute of Medical Sciences
        • Contact:
      • Hyderabad, India, 500082
        • Not yet recruiting
        • Yashoda Hospitals, Somajiguda
        • Contact:
      • Hyderabad, India, 500001
        • Not yet recruiting
        • Glenfield Mallareddy Brain Heart Hospital
        • Contact:
      • Kochi, India, 682 025
        • Not yet recruiting
        • Renai Medicity Multi Super Specialty Hospital
        • Contact:
      • Kolkata, India, 700017
        • Not yet recruiting
        • Institute of Neurosciences Kolkata
        • Contact:
      • Kolkata, India, 700025
        • Not yet recruiting
        • Bangur Institute of Neurosciences
        • Contact:
      • Kozhikode, India, 673004
        • Not yet recruiting
        • Baby Memorial Hospital Kozhikode
        • Contact:
      • Ludhiana, India, 141008
        • Not yet recruiting
        • Christian Medical College, Ludhiana
        • Contact:
      • Nashik, India, 422005
        • Not yet recruiting
        • Chopda Medicare and Research Centre Pvt Ltd
        • Contact:
      • Nellore, India, 524001
        • Not yet recruiting
        • Vijaya Super Speciality Hospital
        • Contact:
      • New Delhi, India, 110017
        • Not yet recruiting
        • Max Super Speciality Hospital
        • Contact:
      • New Delhi, India, 110005
        • Not yet recruiting
        • BLK-Max Super Speciality Hospital, Delhi
        • Contact:
      • New Delhi, India, 110029
        • Not yet recruiting
        • All India Institute of Medical Sciences, New Dehli
        • Contact:
      • New Delhi, India, 1100o1
        • Not yet recruiting
        • Dr. Ram Manohar Lohia Hospital
        • Contact:
      • Ongole, India, 523001
        • Not yet recruiting
        • Government Medical College, Ongole
        • Contact:
      • Patna, India, 800014
        • Not yet recruiting
        • Indira Gandhi Institute of Medical Sciences
        • Contact:
      • Pune, India, 411004
        • Not yet recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
        • Contact:
      • Rajkot, India, 360005
        • Not yet recruiting
        • Synergy Superspeciality Hospital
        • Contact:
      • Rohtak, India, 124001
        • Not yet recruiting
        • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
        • Contact:
      • Rāgolu, India, 532484
        • Not yet recruiting
        • Great Eastern Medical School
        • Contact:
      • Shimla, India, 171001
        • Not yet recruiting
        • Indira Gandhi Medical College & Hospital
        • Contact:
      • Surat, India, 395010
        • Not yet recruiting
        • Unity Hospital
        • Contact:
      • Thane, India, 401107
        • Not yet recruiting
        • Bhaktivedanta Hospital & Research Institute
        • Contact:
      • Thiruvananthapuram, India, 695011
        • Not yet recruiting
        • Sree Chitra Tirunal Institute for Medical Sciences & Technology
        • Contact:
      • Varanasi, India, 221002
        • Not yet recruiting
        • City Neurology Centre
        • Contact:
      • Vellore, India, 632004
        • Not yet recruiting
        • Christian Medical College, Vellore
        • Contact:
      • Vijayawada, India, 520008
        • Not yet recruiting
        • Government Siddhartha Medical College
        • Contact:
      • Visakhapatnam, India, 530040
        • Not yet recruiting
        • Visakha Institute of Medical Sciences
        • Contact:
      • Vizianagaram, India, 535002
        • Not yet recruiting
        • Government Medical College Vizianagaram
        • Contact:
      • Wardha, India, 442004
        • Not yet recruiting
        • Acharya Vinobha Bhave Rural Hospital
        • Contact:
  • Indonesia
      • Badung, Indonesia, 80361
        • Not yet recruiting
        • Siloam Hospitals Denpasar
        • Contact:
      • Bandung, Indonesia, 40233
        • Not yet recruiting
        • Immanuel Hospital Bandung
        • Contact:
      • Jakarta, Indonesia, 10430
        • Not yet recruiting
        • Dr. Cipto Mangunkusumo Hospital
        • Contact:
      • Jakarta, Indonesia, 11530
        • Not yet recruiting
        • Siloam Hospitals Kebon Jeruk
        • Contact:
      • Jakarta, Indonesia, 12430
        • Not yet recruiting
        • Siloam Hospitals TB Simatupang
        • Contact:
      • Jakarta, Indonesia, 13630
        • Not yet recruiting
        • Mahar Mardjono National Brain Center Hospital
        • Contact:
      • Medan, Indonesia, 20212
        • Not yet recruiting
        • Siloam Hospitals Medan
        • Contact:
      • Padang, Indonesia, 25171
        • Not yet recruiting
        • RSUP Dr. M. Djamil
        • Contact:
      • Semarang, Indonesia, 50231
        • Not yet recruiting
        • RSUP Dr. Kariadi
        • Contact:
      • Surabaya, Indonesia, 60115
        • Not yet recruiting
        • Airlangga University Hospital
        • Contact:
      • Tangerang, Indonesia, 15811
        • Not yet recruiting
        • Siloam Hospitals Lippo Village
        • Contact:
      • Yogyakarta, Indonesia
        • Not yet recruiting
        • Sardjito Hospital
        • Contact:
      • Yogyakarta, Indonesia, 55223
        • Not yet recruiting
        • Bethesda Hospital
        • Contact:
      • Yogyakarta, Indonesia, 55291
  • 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
        • Not yet recruiting
        • Hospital Raja Perempuan Zainab II
        • Contact:
      • Kota Bharu, Malaysia, 15200
        • Not yet recruiting
        • Hospital Universiti Sains Malaysia
        • Contact:
      • Kuala Lumpur, Malaysia, 50586
      • Serdang, Malaysia, 43400
        • Not yet recruiting
        • Universiti Putra Malaysia
        • Contact:
  • Norway
      • Bergen, Norway, 5021
        • Not yet recruiting
        • Haukeland University Hospital
        • Contact:
      • Grålum, Norway, 1714
        • Not yet recruiting
        • Sykehuset Ostfold HF
        • Contact:
      • Stavanger, Norway, 4011
        • Not yet recruiting
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
  • Romania
      • Arad, Romania, 310037
        • Not yet recruiting
        • Spitalul Clinic Județean De Urgența Arad
        • Contact:
      • Brasov, Romania, 500326
        • Not yet 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
        • Not yet recruiting
        • Spitalul Judetean de Urgenta Piatra Neamt
        • Contact:
      • Suceava, Romania, 720284
        • Not yet recruiting
        • Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
        • Contact:
      • Târgu Mureş, Romania, 540136
        • Not yet recruiting
        • Spitalul Clinic Judetean de Urgenta Targu Mures
        • Contact:
  • Spain
      • A Coruña, Spain, 15006
        • Not yet 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, 08003
      • Barcelona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron - VHIR
        • Contact:
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Girona, Spain, 17007
        • Not yet recruiting
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital Universitario de La Princesa
        • Contact:
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital Ruber Juan Bravo
        • Contact:
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Hospital Universitario de Salamanca
        • Contact:
      • Seville, Spain, 41009
        • Not yet recruiting
        • Hospital Universitario Virgen de la Macarena
        • Contact:
      • Tarragona, Spain, 43005
        • Not yet recruiting
        • Hospital Universitari Joan XXIII
        • Contact:
      • Terrassa, Spain, 08221
        • Not yet recruiting
        • Hospital Universitari Mutua de Terrasa
        • Contact:
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
      • Vigo, Spain, 36312
        • Not yet recruiting
        • Hospital Alvaro Cunqueiro
        • Contact:
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Clínico Universitario Lozano Blesa
        • Contact:
  • Taiwan
      • Buzi, Taiwan, 61363
        • Not yet recruiting
        • Chang Gung Memorial Hospital Chiayi
        • Contact:
      • Changhua, Taiwan, 50006
        • Not yet recruiting
        • Changhua Christian Hospital
        • Contact:
      • Keelung, Taiwan, 204
        • Not yet recruiting
        • Chang Gung Memorial Hospital-Keelung
        • Contact:
      • New Taipei City, Taiwan, 23561
        • Not yet recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:
      • Taichung, Taiwan, 40447
        • Not yet recruiting
        • China Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 100225
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 114
        • Not yet recruiting
        • Tri-Service General Hospital
        • Contact:
      • Taoyuan City, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10330
        • Not yet recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Siriraj Hospital
        • Contact:
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Ramathibodi Hospital
        • Contact:
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Phramongkutklao Hospital
        • Contact:
      • Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Contact:
      • Khon Kaen, Thailand, 40002
        • Not yet recruiting
        • Srinagarind Hospital
        • Contact:
      • Klong Luang, Thailand, 12120
        • Not yet recruiting
        • Thammasat University Hospital
        • Contact:
      • Lampang, Thailand, 52000
        • Not yet recruiting
        • Lampang Hospital
        • Contact:
      • Muang, Thailand, 34000
        • Not yet recruiting
        • Sunprasitthiprasong Hospital
        • Contact:
  • Vietnam
      • Da Nang, Vietnam, 550000
      • Haiphong, Vietnam
      • Hanoi, Vietnam, 100000
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Nguyen Tri Phuong Hospital
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Nhan Dan Gia Dinh Hospital
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Thong Nhat Hospital HCMC
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Military Hospital 175
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • People's Hospital 115
        • Contact:
      • Ho Chi Minh City, Vietnam, 748806
        • Not yet recruiting
        • University Medical Center HCMC
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
        • Not yet recruiting
        • Le Van Thinh Hospital
        • Contact:
      • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
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
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

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)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 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))

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.

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