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
- Ahmedabad, Bangalore, Belagavi, Bhubaneswar, Bikaner, Calicut, Chandigarh, Coimbatore, Darjeeling, Dehradun, Farīdkot, Ghaziabad, Guntur, Hubli, Hyderabad, Jammu, Kochi, Kolkata, Kozhikode, Ludhiana, Nashik, Nellore, New Delhi, Ongole, Patna, Pune, Rāgolu, Rajkot, Rohtak, Shimla, Surat, Thane, Thiruvananthapuram, Varanasi, Vellore, Vijayawada, Visakhapatnam, Vizianagaram, and Wardha, IndiaSee the 51 sites
- Phase
- Phase 3
Where in India
- Zydus Hospital - AhmedabadAhmedabad, IndiaTaking people
- Bangalore Medical CollegeBangalore, IndiaTaking people
- KLES Dr Prabhakar Kore Hospital and Medical Research CentreBelagavi, IndiaTaking people
- SUM Ultimate MedicareBhubaneswar, IndiaTaking people
- S.P. Medical College & Associated Group of HospitalsBikaner, IndiaTaking people
- Malabar Institute of Medical Sciences Ltd.Calicut, IndiaTaking people
- Post Graduate Institute of Medical Education and ResearchChandigarh, IndiaNot yet recruiting
- K.G. Hospital and Post Graduate Medical InstituteCoimbatore, IndiaTaking people
- North Bengal Medical College and HospitalDarjeeling, IndiaNot yet recruiting
- Max Super Speciality Hospital, DehradunDehradun, IndiaTaking people
- Shri Mahant Indiresh HospitalDehradun, IndiaTaking people
- GGS Medical College & HospitalFarīdkot, IndiaNot yet recruiting
- Max Super Speciality Hospital, VaishaliGhaziabad, IndiaTaking people
- Yashoda MedicityGhaziabad, IndiaNot yet recruiting
- Government General Hospital GunturGuntur, IndiaTaking people
- Lalitha PVS Institute of Medical SciencesGuntur, IndiaTaking people
- Lalitha Super Speciality HospitalGuntur, IndiaNot yet recruiting
- Karnataka Institute of Medical Sciences, HubliHubli, IndiaTaking people
- Glenfield Mallareddy Brain Heart HospitalHyderabad, IndiaTaking people
- Nizam's Institute of Medical SciencesHyderabad, IndiaTaking people
- Renova Century Hospital - Banjara HillsHyderabad, IndiaTaking people
- Yashoda Hospitals, SomajigudaHyderabad, IndiaTaking people
- Government Medical College JammuJammu, IndiaNot yet recruiting
- Renai Medicity Multi Super Specialty HospitalKochi, IndiaTaking people
- Bangur Institute of NeurosciencesKolkata, IndiaTaking people
- Institute of Neurosciences KolkataKolkata, IndiaTaking people
- Baby Memorial Hospital KozhikodeKozhikode, IndiaTaking people
- Christian Medical College, LudhianaLudhiana, IndiaTaking people
- Chopda Medicare and Research Centre Pvt LtdNashik, IndiaTaking people
- Sahyadri Superspeciality Hospital, NashikNashik, IndiaTaking people
- Vijaya Super Speciality HospitalNellore, IndiaTaking people
- All India Institute of Medical Sciences, New DehliNew Delhi, IndiaTaking people
- BLK-Max Super Speciality Hospital, DelhiNew Delhi, IndiaTaking people
- Dr. Ram Manohar Lohia HospitalNew Delhi, IndiaNot yet recruiting
- Max Super Speciality HospitalNew Delhi, IndiaTaking people
- Government Medical College, OngoleOngole, IndiaTaking people
- Indira Gandhi Institute of Medical SciencesPatna, IndiaTaking people
- Deenanath Mangeshkar Hospital and Research CentrePune, IndiaTaking people
- Great Eastern Medical SchoolRāgolu, IndiaTaking people
- Synergy Superspeciality HospitalRajkot, IndiaNot yet recruiting
- Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical SciencesRohtak, IndiaTaking people
- Indira Gandhi Medical College & HospitalShimla, IndiaTaking people
- Unity HospitalSurat, IndiaTaking people
- Bhaktivedanta Hospital & Research InstituteThane, IndiaNot yet recruiting
- Sree Chitra Tirunal Institute for Medical Sciences & TechnologyThiruvananthapuram, IndiaTaking people
- City Neurology CentreVaranasi, IndiaTaking people
- Christian Medical College VelloreVellore, IndiaTaking people
- Government Siddhartha Medical CollegeVijayawada, IndiaTaking people
- Visakha Institute of Medical SciencesVisakhapatnam, IndiaTaking people
- Government Medical College VizianagaramVizianagaram, IndiaTaking people
- Acharya Vinobha Bhave Rural HospitalWardha, IndiaNot yet recruiting
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.