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Effectiveness of Tenecteplase in Acute Ischemic Stroke Patients Treated 4.5–24 Hours After Onset Before Transfer for Thrombectomy

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on Acute ischemic stroke, a condition where blood flow to part of the brain is suddenly blocked, leading to loss of function. The study medication is tenecteplase, a drug given through an IV (a needle placed in a vein) to help dissolve the clot before the patient is moved to another hospital for a possible thrombectomy, a procedure that physically removes the clot.

The purpose of the study is to determine whether giving the drug in the 4.5‑ to 24‑hour window after the stroke improves recovery compared with a placebo. Participants will be randomly assigned to receive either the medication or the placebo, and will undergo brain imaging with CT or MRI to confirm that there is still brain tissue that can be saved. Recovery will be measured at 90 days using the modified Rankin Scale, a simple questionnaire that rates how well a person can perform everyday activities.

After enrollment, the study drug is administered intravenously, and the patient is transferred to a specialized center for the possible endovascular procedure. Follow‑up includes additional brain scans to check for bleeding, phone interviews to assess daily function, and a final health evaluation at three months. All assessments are performed by staff who do not know which treatment the participant received.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After agreeing to participate, you will sign a consent form that explains the study and your rights.
The study staff will confirm that you have an acute ischemic stroke and meet the eligibility criteria.
Step 2
Baseline clinical assessment
A nurse or doctor will record your medical history, current symptoms, and vital signs.
Your stroke severity will be measured using the nihss (national institutes of health stroke scale) score.
Step 3
Brain imaging
You will undergo a ct (computed tomography) scan or mri (magnetic resonance imaging) to check for salvageable brain tissue.
The images will be reviewed to determine if you have a large vessel occlusion that could benefit from further treatment.
Step 4
Randomization
Based on the imaging results, you will be randomly assigned to receive either the study medication or standard care.
The assignment is done by a computer system, and you will not know which group you are in.
Step 5
Administration of tenecteplase
If you are assigned to the medication group, you will receive a single intravenous (iv) injection of tenecteplase.
The dose is calculated as 0.25 mg per kilogram of your body weight.
The injection is given as a single bolus between 4.5 and 24 hours after the last time you were known to be well.
Step 6
Preparation for inter‑hospital transfer
After the injection, you will be prepared for transfer to a hospital that can perform an endovascular thrombectomy (evt).
Transport is arranged by the study team and follows standard emergency medical protocols.
Step 7
Endovascular thrombectomy (if performed)
Upon arrival at the evt‑capable center, doctors may perform a mechanical clot‑removal procedure called endovascular thrombectomy.
The decision to proceed is based on the imaging and clinical findings at that time.
Step 8
Follow‑up brain imaging
Within 36 hours of randomization, a repeat brain scan will be done to look for any bleeding or changes in the clot.
The scan helps assess safety outcomes such as parenchymal hemorrhage.
Step 9
Clinical assessment at 24‑36 hours
Your stroke severity will be re‑evaluated using the nihss score.
The study looks for improvement of at least 8 points or a score of 1 or less at this time point.
Step 10
90‑day follow‑up
Approximately three months after the stroke, a study coordinator will call you or a caregiver.
The call includes the modified rankin scale questionnaire to assess functional outcome and the eq‑5d‑3l quality‑of‑life questionnaire.
Information about any adverse events, including death, will also be collected.

Who can join the trial?

12 criteria

Age: You must be 18 years old or older.
Time window: You must be admitted to a primary stroke center within 4.5 to 24 hours after your stroke symptoms began, or after the last time you were known to be well if the exact start time is unknown.
NIHSS score of 6 or higher: This is a test that measures how severe your stroke symptoms are; a score of 6 or more indicates a moderate to severe stroke.
Large vessel occlusion seen on brain imaging: A scan must show a blockage in a major brain artery such as the internal carotid artery, the first or second part of the middle cerebral artery (called M1 or proximal M2), or the basilar artery.
Target mismatch profile indicating salvageable brain tissue:
- If a special scan called perfusion imaging is done, the results must show:
  - an estimated core of dead tissue no larger than 70 mL,
  - a “Tmax 6” volume of at least 30 mL (a measure of delayed blood flow),
  - a mismatch ratio of 1.8 or greater, and
  - a mismatch volume of at least 15 mL (areas that may still be saved).
  - If perfusion imaging is not available, a standard CT or MRI scan must show an ASPECTS score that meets one of these:
    
    Score 6 or higher for a blockage in the internal carotid artery or the M1 segment,
    Score 7 or higher for a blockage in the M2 segment, or
    Score 7 or higher for a blockage in the basilar artery.
    Inter‑hospital transfer needed for an endovascular procedure: You must require transfer to another hospital for a clot‑removing treatment performed through a small tube inserted into the blood vessels.

Who cannot join the trial?

5 criteria

You cannot take part if you have any condition that makes the clot‑busting medicine (IV thrombolysis) unsafe, such as: inability to lower blood pressure below 185/110 mmHg, severe breathing or heart‑circulation failure, allergy (hypersensitivity) to the drug, its ingredients, or to gentamicin (a tiny residue from manufacturing), known bleeding tendency (haemorrhagic diathesis), infections of the heart lining (bacterial endocarditis) or heart sac (pericarditis), acute inflammation of the pancreas (acute pancreatitis), serious liver problems (failure, cirrhosis, high pressure in the portal vein, or esophageal varices), active ulcer disease in the stomach or intestines, cancer that raises the risk of bleeding, very low platelet count (thrombocytopenia, < 100 G/L) or clotting disorders (INR > 1.7, activated partial thromboplastin time > 40 s, or prothrombin time > 15 s) now or in the past 3 weeks, use of strong blood thinners such as oral anticoagulants (e.g., vitamin K antagonists) with INR > 1.7, a brain tumor (intracerebral neoplasm), brain or spinal surgery or acute spinal cord injury within the last 3 months, a recent heart attack with ST‑segment elevation (ST‑segment elevation myocardial infarction) within 3 months, major non‑brain surgery, organ biopsy, or serious injury within the last 10 days, recent moderate to severe head injury, abnormal blood‑vessel formations (arterial or venous malformation) except an unruptured brain aneurysm, a brain bleed (intracerebral haemorrhage) within 3 months, a condition called cerebral amyloid angiopathy, or another acute ischemic stroke within the last 3 months.
You cannot take part if, before your stroke, you already needed help with most daily activities (a pre‑stroke modified Rankin Scale score greater than 2).
You cannot take part if you are known to be pregnant or are currently breastfeeding.
You cannot take part if a court has placed you under legal protection, meaning you cannot make medical decisions on your own.
You cannot take part if you are already enrolled in another interventional clinical study for the period you would be followed up in this trial.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centre Hospitalier De Roubaix
Verified
Roubaix, France

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Investigated drugs

Tenecteplase is a clot‑dissolving medication given through an IV line. In this study it is used for patients who have had an acute stroke caused by a large clot in a brain artery. The drug works by breaking down the clot, helping to restore blood flow to the part of the brain that is at risk. It is given before the patient is transferred to another hospital for a mechanical procedure to remove the clot, with the goal of improving recovery and functional ability after 90 days.

Tenecteplase

What is already known about the treatment

Tenecteplase - Tenecteplase is supplied as a powder that is mixed with liquid and given by IV injection. It is an approved clot‑busting drug used for heart attacks and is now being studied for treating acute stroke, so it is well documented in medical literature. It works by activating a natural protein that becomes an enzyme which breaks down the material holding a blood clot together, helping restore blood flow. It belongs to the class of thrombolytic (fibrinolytic) agents.

Investigated diseases

Acute ischemic stroke - A sudden blockage of a blood vessel in the brain stops oxygen and nutrients from reaching brain tissue. Within minutes, the affected area begins to lose function as brain cells start to die. The loss of blood flow can spread outward, enlarging the region of damage if the blockage is not cleared. Symptoms such as weakness, speech difficulty, or visual changes appear quickly and may worsen over the first hours. Early changes in the brain can be seen on imaging studies, showing areas of reduced blood flow that may still be salvageable. The condition evolves as the initial injury stabilizes and the brain begins to reorganize around the damaged zone.