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
NCT07361302
Phase
Phase 3
Recruitment status
Recruiting
Participants
1,325
Lead sponsor
Boehringer Ingelheim
Start date
2026-02-17
Number of sites
- 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. 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.
- Acronym
- TENACITY
- Short 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
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-10-02
- First posted
- 2026-01-23
- Registry last updated
- 2026-08-20
- Primary completion date
- 2027-10-02
- Start date
- 2026-02-17
- Participants
- 1,325
- Participant count basis
- Estimated
- Planned participants
- 1,325
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Boehringer Ingelheim
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07361302
- ClinicalTrials.gov ID
- NCT07361302
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
modified Rankin Scale (mRS) score of 0-1 at Day 90
Timeframe: 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.
mRS (ordinal) at Day 90
Timeframe: 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)
Timeframe: 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.
mRS 0-2 at Day 90
Timeframe: at Day 90
Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h
Timeframe: after 36 hours
sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h
Timeframe: after 36 hours
Death from any cause within 90 days
Timeframe: up to 90 days
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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)
- 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)
- 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.
Sources for eligibility
- Sanatorio GüemesBuenos Aires, ArgentinaRecruiting
- Hospital Italiano de Buenos AiresCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting
- CEMICCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting
- Hospital General de Agudos Dr. J. M. Ramos MejiaCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting
- Clinica La Sagrada FamiliaCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting
- Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENICiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting
- Complejo Medico de la Policia Federal Argentina Churruca ViscaCiudad Autonoma Buenos Aires, ArgentinaNot yet recruiting
- Clinica Privada Velez SarfieldCórdoba, ArgentinaRecruiting
- Nuevo Hospital San RoqueCórdoba, ArgentinaRecruiting
- Sanatorio AllendeCórdoba, ArgentinaRecruiting
- Sanatorio Privado Duarte Quiros De Clinica Colombo SACórdoba, ArgentinaRecruiting
- Sanatorio de la CanadaCórdoba, ArgentinaRecruiting
- Hospital CordobaCórdoba, ArgentinaRecruiting
- Hospital Privado de ComunidadMar del Plata, ArgentinaNot yet recruiting
- Hospital Universitario AustralPilar, ArgentinaNot yet recruiting
- Hospital Privado de RosarioRosario, ArgentinaNot yet recruiting
- Campbelltown HospitalCampbelltown, AustraliaNot yet recruiting
- Liverpool HospitalLiverpool, AustraliaRecruiting
- John Hunter HospitalNew Lambton Heights, AustraliaRecruiting
- Royal Adelaide HospitalAdelaide, AustraliaRecruiting
- Eastern Health-Box Hill HospitalBox Hill, AustraliaRecruiting
- Monash Medical CentreClayton, AustraliaNot yet recruiting
- Royal Melbourne HospitalParkville, AustraliaRecruiting
- MHAT "Puls" ADBlagoevgrad, BulgariaRecruiting
- MHAT Blagoevgrad, EOODBlagoevgrad, BulgariaNot yet recruiting
And 225 more, listed on the interactive page.
Sources for sites
- Related resource (www.clinicalstudies.boehringer-ingelheim.com)
- 2025
- 2025-522542-40-00
- U1111-1323-6001
Sources for references
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Ischemic stroke
- Transient ischemic attack Primary condition