Tests tenecteplase for acute ischemic stroke given more than 4.5 hours after onset
Tests tenecteplase in adults with a late acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Anyang, Baoji, Baotou, Beijing, Cangzhou, Changchun, Changsha, Chengdu, Chifeng, Daqing, Foshan, Fushun, Guangzhou, Haerbin, Hengyang, Huai'an, Huizhou, Jilin City, Jinhua, Jining, Jiujiang, Kunming, Liaocheng, Linfen, Linyi, Lu'an, Luoyang, Nanjing, Nanyang, Ordos, Pingxiang, Qingdao, Shanghai, Shangrao, Shaoguan, Shenyang, Shijiazhuang, Shiyan, Sichuan, Taiyuan, Tengzhou, Weifang, Wenzhou, Wuhan, Xinxiang, Xuancheng, Xuzhou, Yantai, Yulin, Zhangzhou, Zhengzhou, Zhumadian, and Zigong, ChinaSee the 63 sites
- Phase
- Phase 3
Where in China
- The People's Hospital of Anyang CityAnyang, ChinaTaking people
- Baoji Central HospitalBaoji, ChinaTaking people
- Inner Mongolia Baogang HospitalBaotou, ChinaTaking people
- Cap Med UniversityBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaTaking people
- Hebei Cangzhou Central HospitalCangzhou, ChinaTaking people
- Jilin Cancer HospitalChangchun, ChinaTaking people
- Hunan Provincial People's HospitalChangsha, ChinaTaking people
- Chengdu Second People's HospitalChengdu, ChinaTaking people
- Chifeng Traditional Chinese and Mongolian Medicine HospitalChifeng, ChinaTaking people
- Daqing Longnan HospitalDaqing, ChinaTaking people
- Daqing Oilfield General HospitalDaqing, ChinaTaking people
- The First People's Hospital of FoshanFoshan, ChinaTaking people
- General Hospital of Fushun Mining BureauFushun, ChinaTaking people
- Third Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- The Second Hospital of Harbin Medical UniversityHaerbin, ChinaNot yet recruiting
- The First Affiliated Hospital of University of South ChinaHengyang, ChinaTaking people
- Huai'an Second People's HospitalHuai'an, ChinaTaking people
- Huizhou Central People's HospitalHuizhou, ChinaNot yet recruiting
- Huizhou First HospitalHuizhou, ChinaTaking people
- Meihekou Central HospitalJilin City, ChinaTaking people
- Jinhua Municipal Central HospitalJinhua, ChinaTaking people
- Jining No. 1 People's Hospital.Jining, ChinaTaking people
- Affiliated Hospital of Jiujiang UniversityJiujiang, ChinaNot yet recruiting
- First People's Hospital of Yunnan ProvinceKunming, ChinaTaking people
- Liaocheng People's HospitalLiaocheng, ChinaTaking people
- Linfen Central HospitalLinfen, ChinaTaking people
- Linyi People's HospitalLinyi, ChinaTaking people
- Lu'an People's HospitalLu'an, ChinaNot yet recruiting
- Luoyang Central HospitalLuoyang, ChinaNot yet recruiting
- The Second Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaTaking people
- The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- Nanyang Central HospitalNanyang, ChinaTaking people
- Nanyang Nanshi HospitalNanyang, ChinaTaking people
- Ordos Central HostipalOrdos, ChinaNot yet recruiting
- Pingxiang People's HospitalPingxiang, ChinaTaking people
- Qingdao Central HospitalQingdao, ChinaTaking people
- QingDao Municipal HospitalQingdao, ChinaTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Shanghai Tenth People's HospitalShanghai, ChinaNot yet recruiting
- Shangrao People's HospitalShangrao, ChinaTaking people
- Yuebei People's HospitalShaoguan, ChinaTaking people
- Affiliated Central Hospital of Shenyang Medical CollegeShenyang, ChinaTaking people
- The First People's Hospital of ShenyangShenyang, ChinaTaking people
- Hebei General HospitalShijiazhuang, ChinaTaking people
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaNot yet recruiting
- Shiyan Taihe HospitalShiyan, ChinaNot yet recruiting
- Sichuan Provincial People's HospitalSichuan, ChinaTaking people
- Shanxi Cardiovascular HospitalTaiyuan, ChinaTaking people
- The First People's Hospital of TanchengTengzhou, ChinaTaking people
- Weifang People's HospitalWeifang, ChinaNot yet recruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- The Central Hospital of WuhanWuhan, ChinaTaking people
- Wuhan Puai HospitalWuhan, ChinaTaking people
- Xinxiang Central HospitalXinxiang, ChinaTaking people
- The People's Hospital Of Xuancheng CityXuancheng, ChinaTaking people
- Xuzhou Central HospitalXuzhou, ChinaTaking people
- Yantai Yuhuangding HospitalYantai, ChinaTaking people
- Yulin First People's HospitalYulin, ChinaTaking people
- Zhangzhou Municipal Hospital of Fujian ProvinceZhangzhou, ChinaTaking people
- Zhengzhou Central HospitalZhengzhou, ChinaNot yet recruiting
- Zhumadian Central HospitalZhumadian, ChinaNot yet recruiting
- Zigong No. 1 People's HospitalZigong, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07361302EU 2025-522542-40-00
- Record updated
- 10 November 2026
- Original description
This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: High-risk patients (increased risk of thrombolysis related hemorrhage); Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans; Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) > 25); 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; Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation; Occlusion of the internal carotid artery (ICA); Contra-indication to contrast brain imaging with CT and MRI; Patients scheduled to receive intravenous (i.v.) thrombolysis as standard of care Further exclusion criteria apply.