Acute Ischemic StrokePhase 3TENACITYNCT07361302
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
A Phase 3 study testing Tenecteplase in people with Acute Ischemic Stroke, run by Boehringer Ingelheim at 254 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tenecteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,325 participants
- Where
- 254 sitesin 16 countries
- Study dates
- 17 Feb 2026to 2 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation
- Occlusion of the internal carotid artery (ICA)
- High-risk patients (increased risk of thrombolysis related hemorrhage)
- Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans
- Contra-indication to contrast brain imaging with CT and MRI
- Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) > 25)
Show all 9Show fewer
- Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
- Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
- Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.
Trial locations and contacts
254 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
254 sites in 16 countries
China59 sites, 59 recruiting
- Recruiting
The People's Hospital of Anyang City
Anyang, 455002
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Baoji Central Hospital
Baoji, 721008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Inner Mongolia Baogang Hospital
Baotou, 14010
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Cap Med University
Beijing, 100069
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Peking University Third Hospital
Beijing, 100191
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Hebei Cangzhou Central Hospital
Cangzhou, 61001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Jilin Cancer Hospital
Changchun, 130000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Hunan Provincial People's Hospital
Changsha, 410005
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Chengdu Second People's Hospital
Chengdu, 610021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Chifeng Traditional Chinese and Mongolian Medicine Hospital
Chifeng, 24005
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Daqing Longnan Hospital
Daqing, 163000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Daqing Oilfield General Hospital
Daqing, 163001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First People's Hospital of Foshan
Foshan, 528000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
General Hospital of Fushun Mining Bureau
Fushun, 113008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The Second Hospital of Harbin Medical University
Haerbin, 150086
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, 421001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Huai'an Second People's Hospital
Huai'an, 223002
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Huizhou Central People's Hospital
Huizhou, 516001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Huizhou First Hospital
Huizhou, 516003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Meihekou Central Hospital
Jilin City, 135000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, 321000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Jining No.1 People's Hospital
Jining, 272011
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Affiliated Hospital of Jiujiang University
Jiujiang, 332000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
First People's Hospital of Yunnan Province
Kunming, 650032
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Liaocheng People's Hospital
Liaocheng, 252000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Linfen Central Hospital
Linfen, 041000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Linyi People's Hospital
Linyi, 276005
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Lu'an People's Hospital
Lu'an, 237005
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Luoyang Central Hospital
Luoyang, 471009
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Nanyang Central Hospital
Nanyang, 473000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Nanyang Nanshi Hospital
Nanyang, 473001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Pingxiang People's Hospital
Pingxiang, 337055
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Qingdao Central Hospital
Qingdao, 266024
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Qingdao Municipal Hospital
Qingdao, 266071
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, 200072
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shangrao People's Hospital
Shangrao, 334000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Yuebei People's Hospital
Shaoguan, 512026
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Affiliated Central Hospital of Shenyang Medical College
Shenyang, 110000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First People's Hospital of Shenyang
Shenyang, 110000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Hebei General Hospital
Shijiazhuang, 500051
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sichuan Provincial People's Hospital
Sichuan, 610031
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanxi Cardiovascular Hospital
Taiyuan, 30013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First People's Hospital of Tancheng
Tengzhou, 276199
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Weifang People's Hospital
Weifang, 261000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Central Hospital of Wuhan
Wuhan, 430014
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Wuhan Puai Hospital
Wuhan, 430033
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Xinxiang Central Hospital
Xinxiang, 453000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The People's Hospital Of Xuancheng City
Xuancheng, 242000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Xuzhou Central Hospital
Xuzhou, 221009
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, 264000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Yulin First People's Hospital
Yulin, 537000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, 363000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Zhengzhou Central Hospital
Zhengzhou, 450007
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Zigong No. 1 People's Hospital
Zigong, 643000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
India51 sites, 51 recruiting
- Recruiting
Zydus Hospital - Ahmedabad
Ahmedabad, 380054
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Bangalore Medical College
Bangalore, 560002
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, 590010
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
SUM Ultimate Medicare
Bhubaneswar, 751003
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
S.P. Medical College & Associated Group of Hospitals
Bikaner, 334 003
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Malabar Institute of Medical Sciences Ltd.
Calicut, 673016
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
K.G. Hospital and Post Graduate Medical Institute
Coimbatore, 641018
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
North Bengal Medical College and Hospital
Darjeeling, 734 012
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Max Super Speciality Hospital, Dehradun
Dehradun, 248001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Shri Mahant Indiresh Hospital
Dehradun, 248001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
GGS Medical College & Hospital
Farīdkot, 151203
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Max Super Speciality Hospital, Vaishali
Ghaziabad, 201012
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Yashoda Medicity
Ghaziabad, 201014
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Government General Hospital Guntur
Guntur, 522001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Lalitha PVS Institute of Medical Sciences
Guntur, 522001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Lalitha Super Speciality Hospital
Guntur, 522001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Karnataka Institute of Medical Sciences, Hubli
Hubli, 580021
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Glenfield Mallareddy Brain Heart Hospital
Hyderabad, 500001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Renova Century Hospital - Banjara Hills
Hyderabad, 500028
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Nizam's Institute of Medical Sciences
Hyderabad, 500082
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Yashoda Hospitals, Somajiguda
Hyderabad, 500082
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Government Medical College Jammu
Jammu, 180016
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Renai Medicity Multi Super Specialty Hospital
Kochi, 682 025
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Institute of Neurosciences Kolkata
Kolkata, 700017
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Bangur Institute of Neurosciences
Kolkata, 700025
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Baby Memorial Hospital Kozhikode
Kozhikode, 673004
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Christian Medical College, Ludhiana
Ludhiana, 141008
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Chopda Medicare and Research Centre Pvt Ltd
Nashik, 422005
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Sahyadri Superspeciality Hospital, Nashik
Nashik, 422011
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Vijaya Super Speciality Hospital
Nellore, 524001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
BLK-Max Super Speciality Hospital, Delhi
New Delhi, 110005
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Max Super Speciality Hospital
New Delhi, 110017
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
All India Institute of Medical Sciences, New Dehli
New Delhi, 110029
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Dr. Ram Manohar Lohia Hospital
New Delhi, 1100o1
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Government Medical College, Ongole
Ongole, 523001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Indira Gandhi Institute of Medical Sciences
Patna, 800014
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Great Eastern Medical School
Rāgolu, 532484
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Synergy Superspeciality Hospital
Rajkot, 360005
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Indira Gandhi Medical College & Hospital
Shimla, 171001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Unity Hospital
Surat, 395010
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Bhaktivedanta Hospital & Research Institute
Thane, 401107
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Thiruvananthapuram, 695011
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
City Neurology Centre
Varanasi, 221002
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Christian Medical College, Vellore
Vellore, 632004
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Government Siddhartha Medical College
Vijayawada, 520008
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Visakha Institute of Medical Sciences
Visakhapatnam, 530040
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Government Medical College Vizianagaram
Vizianagaram, 535002
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Acharya Vinobha Bhave Rural Hospital
Wardha, 442004
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Spain21 sites, 21 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital General Universitario Dr. Balmis
Alicante, 03010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario de Cruces
Barakaldo, 48903
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Germans Trias i Pujol
Barcelona, 08916
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Ruber Juan Bravo
Madrid, 28006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario De La Princesa
Madrid, 28006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen De La Macarena
Seville, 41009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitari Joan XXIII
Tarragona, 43005
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Mutua de Terrasa
Terrassa, 08221
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Álvaro Cunqueiro
Vigo, 36312
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Bulgaria19 sites, 19 recruiting
- Recruiting
MHAT "Puls" AD
Blagoevgrad, 2700
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
MHAT Blagoevgrad, EOOD
Blagoevgrad, 2700
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
MHAT Heart and brain
Burgas, 8000
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
MHAT Sv. Ivan Rilski EOOD
Gorna Oryahovitsa, 5100
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
MHAT City Clinic Saint Georgi Ltd
Montana, 3400
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Not yet recruiting
MHAT Heart and brain
Pleven, 5800
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, 5803
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
UMHAT "Kaspela", EOOD
Plovdiv, 4000
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
UMHAT "Sv. Georgi", EAD
Plovdiv, 4002
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
UMHAT Kanev AD
Rousse, 7000
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
UMHAT "Medika Ruse" OOD
Rousse, 7013
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Silven, 8800
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
MHATNP "Sv. Naum" EAD
Sofia, 1113
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
University First MHAT-Sofia "St. Joan Krastitel" EAD
Sofia, 1142
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, 1407
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
Medical Military Academy MHAT Sofia
Sofia, 1606
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, 1606
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Recruiting
University Hospital St. Anna
Sofia, 1750
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Not yet recruiting
MHAT 'Sv. Anna - Varna' AD
Varna, 9002
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Argentina16 sites, 16 recruiting
- Recruiting
Sanatorio Güemes
Buenos Aires, C1180AAX
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Not yet recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, 1199
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Not yet recruiting
CEMIC
Ciudad Autonoma Buenos Aires, 1431
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Not yet recruiting
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, C1221ADC
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica La Sagrada Familia
Ciudad Autonoma Buenos Aires, C1426EOB
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Not yet recruiting
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
Ciudad Autonoma Buenos Aires, C1428AQK
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Not yet recruiting
Complejo Medico de la Policia Federal Argentina Churruca Visca
Ciudad Autonoma Buenos Aires, C1437JCP
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica Privada Velez Sarfield
Córdoba, 5000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Nuevo Hospital San Roque
Córdoba, 5000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio Allende
Córdoba, 5000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio Privado Duarte Quiros De Clinica Colombo SA
Córdoba, 5000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio de la Canada
Córdoba, X5000BSQ
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Hospital Cordoba
Córdoba, X5004CDT
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Not yet recruiting
Hospital Privado de Comunidad
Mar del Plata, B7602CBM
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Hospital Universitario Austral
Pilar, B1629ODT
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Hospital Privado de Rosario
Rosario, S2000GAP
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Indonesia14 sites, 14 recruiting
- Recruiting
Siloam Hospitals Denpasar
Badung, 80361
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Not yet recruiting
Immanuel Hospital Bandung
Bandung, 40233
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Dr. Cipto Mangunkusumo Hospital
Jakarta, 10430
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Siloam Hospitals Kebon Jeruk
Jakarta, 11530
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Siloam Hospitals TB Simatupang
Jakarta, 12430
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Mahar Mardjono National Brain Center Hospital
Jakarta, 13630
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Siloam Hospitals Medan
Medan, 20212
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
RSUP Dr. M. Djamil
Padang, 25171
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
RSUP Dr. Kariadi
Semarang, 50231
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Airlangga University Hospital
Surabaya, 60115
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Siloam Hospitals Lippo Village
Tangerang, 15811
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Bethesda Hospital
Yogyakarta, 55223
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
RS Akademik UGM
Yogyakarta, 55291
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Sardjito Hospital
Yogyakarta
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
Greece13 sites, 13 recruiting
- Not yet recruiting
University General Hospital of Alexandroupolis
Alexandroupoli, 681 00
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
Athens Euroclinic S.A.
Athens, 115 21
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
Athens Naval Hospital
Athens, 115 21
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
Eginitio Hospital
Athens, 11528
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
General Hospital of Athens "Alexandra"
Athens, 11528
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
University General Hospital Attikon
Athens, 12462
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
Metropolitan Hospital
Athens, Neo Faliro, 185 47
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
University General Hospital of Heraklion
Heraklion, 715 00
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
University General Hospital of Larissa
Larissa, 411 10
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
General University Hospital of Patras
Pátrai, 265 04
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 546 36
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
Hippokration General Hospital of Athen
Thessaloniki, 546 42
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, 564 29
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Vietnam11 sites, 11 recruiting
- Not yet recruiting
Da Nang Hospital
Da Nang, 550000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Recruiting
Viet Tiep Hospital
Haiphong
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
Bach Mai hospital
Hanoi, 100000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Recruiting
Le Van Thinh Hospital
Ho Chi Minh City, 700000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
Military Hospital 175
Ho Chi Minh City, 700000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 700000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Recruiting
Nhan Dan Gia Dinh Hospital
Ho Chi Minh City, 700000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
People's Hospital 115
Ho Chi Minh City, 700000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Recruiting
Thong Nhat Hospital HCMC
Ho Chi Minh City, 700000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
University Medical Center HCMC
Ho Chi Minh City, 748806
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
Phu Tho General Hospital
Viet Tri, 290000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
Taiwan9 sites, 9 recruiting
- Recruiting
Chang Gung Memorial Hospital Chiayi
Buzi, 61363
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Changhua Christian Hospital
Changhua, 50006
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Chang Gung Memorial Hospital-Keelung
Keelung, 204
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
China Medical University Hospital
Taichung, 40447
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Tri-Service General Hospital
Taipei, 114
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Thailand9 sites, 9 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Phramongkutklao Hospital
Bangkok, 10400
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Not yet recruiting
Ramathibodi Hospital
Bangkok, 10400
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Not yet recruiting
Siriraj Hospital
Bangkok, 10700
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Srinagarind Hospital
Khon Kaen, 40002
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Thammasat University Hospital
Klong Luang, 12120
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Lampang Hospital
Lampang, 52000
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Sunprasitthiprasong Hospital
Muang, 34000
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
Hungary8 sites, 8 recruiting
- Recruiting
Semmelweis University
Budapest, 1083
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Budapesti Uzsoki Utcai Korhaz
Budapest, 1145
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Pest Megyei Flor Ferenc Hospital
Kistarcsa, 2143
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Pecs
Pécs, 7623
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Szeged
Szeged, 6725
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Australia7 sites, 7 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 3128
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Malaysia6 sites, 6 recruiting
- Not yet recruiting
Hospital Pengajar UiTM Puncak Alam
Bandar Puncak Alam, 43000
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Not yet recruiting
Hospital Raja Permaisuri Bainun
Ipoh, 30450
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Hospital Universiti Sains Malaysia
Kota Bharu, 15200
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Hospital Raja Perempuan Zainab II
Kota Bharu, 15586
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Universiti Putra Malaysia
Serdang, 43400
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
Romania6 sites, 6 recruiting
- Recruiting
Spitalul Clinic Județean De Urgența Arad
Arad, 310037
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, 500326
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Not yet recruiting
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, 900591
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, 610136
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, 720284
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, 540136
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Norway3 sites, 3 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen, 5021
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
Sykehuset Ostfold HF
Grålum, 1714
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
Kazakhstan2 sites, 2 recruiting
- Not yet recruiting
City Multidisciplinary Hospital No 2
Astana, 10000
Boehringer Ingelheim, 88000808264, kazakhstan@bitrialsupport.com
- Not yet recruiting
National Coordination Center for Emergency Medicine
Astana, 10000
Boehringer Ingelheim, 88000808264, kazakhstan@bitrialsupport.com
About this study
Official title: TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue
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.
Read more
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tenecteplase, Standard of care treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
Tenecteplase
Standard of care treatmentDrug
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase treatment arm | Experimental | Not described Receives: Drug: Tenecteplase |
| Standard of care treatment arm | Active comparator | Not described Receives: Drug: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS) score of 0-1 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.
Measured: at day 90
Secondary outcomes (6)
mRS (ordinal) at Day 90
Measured: 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)
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.
Measured: at baseline/randomisation, 24 hours after randomization
mRS 0-2 at Day 90
Measured: at Day 90
Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h
Measured: after 36 hours
sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h
Measured: after 36 hours
Death from any cause within 90 days
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start17 Feb 2026
- Primary completion2 Oct 2027 (estimated)
- Study completion2 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361302
- Sponsor's protocol ID
- 1123-0060
- Other IDs
- 2025-522542-40-00, U1111-1323-6001, 2025
- Acronym
- TENACITY
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.