Recruiting NCT07361302

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

Phase III Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Tenecteplase, Standard of care treatment.
Who it may be relevant to: Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Argentina, Australia, Bulgaria, China, Greece +11
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

Drug Tenecteplase
Tenecteplase
Drug Standard of care treatment
Standard of care treatment

Primary outcome measures

modified Rankin Scale (mRS) score of 0-1 at Day 90 [Time frame: at day 90]

Secondary outcome measures (6)

mRS (ordinal) at Day 90 [Time frame: 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]
mRS 0-2 at Day 90 [Time frame: 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]
sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h [Time frame: after 36 hours]
Death from any cause within 90 days [Time frame: up to 90 days]

Eligibility criteria

Inclusion criteria

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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment