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A study testing tenecteplase given directly into the artery after blood clot removal in patients with acute ischemic stroke in the front part of the brain

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

This study involves patients who have experienced acute ischemic stroke, which is a condition where a blood clot blocks a blood vessel in the brain, cutting off the blood supply and potentially causing brain damage. The blockage occurs specifically in the front part of the brain's blood circulation system. The study will test a medication called Tenecteplase, which is a clot-dissolving drug, and compare it to placebo. The medication will be given directly into the affected blood vessel in the brain after a procedure has been performed to remove the clot mechanically using special instruments inserted through the blood vessels.

The purpose of this study is to find out whether giving Tenecteplase directly into the brain's blood vessel after successful removal of the clot leads to better recovery compared to not giving this additional treatment. The study will measure success by looking at how well patients can function in their daily lives three months after the stroke, specifically checking if they have little to no disability. During the study, patients will first undergo a procedure to remove the blood clot from their brain using mechanical methods. If this procedure successfully reopens the blocked blood vessel, patients will then receive either the clot-dissolving medication or placebo injected directly into the artery in the brain.

The study will follow patients for 90 days after treatment to assess their recovery and ability to perform daily activities. The treatment must be given within 24 hours from when the stroke symptoms began or from when the patient was last known to be well. Patients enrolled in this study will have experienced a stroke caused by a blockage in one of the major blood vessels supplying the front part of the brain, and they must have had successful reopening of this vessel during the mechanical clot removal procedure.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment procedure
After experiencing an acute ischemic stroke (a condition where blood flow to part of the brain is blocked), imaging of your brain will be performed using either CT (computed tomography) or MRI (magnetic resonance imaging) scans to confirm the presence of a large vessel occlusion (blockage of a major blood vessel) in the front part of your brain.
A procedure called catheter angiography will be performed before the mechanical removal of the blockage to confirm the location of the vessel occlusion.
Your stroke symptoms will be assessed using the NIHSS (a scale that measures the severity of stroke symptoms, ranging from 4 to 25 points in this study).
The blockage must be located in specific arteries: the distal ICA (internal carotid artery), Carotid-T, M1, or proximal M2 (branches of the middle cerebral artery).
Step 2
Mechanical removal of blood clot
A procedure called thrombectomy will be performed to mechanically remove the blood clot from the blocked artery in your brain.
The success of this procedure will be evaluated using the eTICI scale, which measures how well blood flow has been restored. A score of eTICI 2b50 or higher indicates successful removal of the blockage.
Step 3
Study medication administration
After successful removal of the blockage, you will receive either tenecteplase or a placebo (an inactive substance with no medication).
The assignment to either tenecteplase or placebo will be random, meaning it will be determined by chance.
Tenecteplase is a medication that helps dissolve blood clots. If assigned to receive it, the dose will be 5,000 units (25 mg).
The medication or placebo will be administered intra-arterially, meaning it will be delivered directly into the artery in your brain through the catheter that was used during the thrombectomy procedure.
This administration will occur immediately following the successful mechanical removal of the clot.
Step 4
Follow-up assessment at 90 days
Your functional recovery will be evaluated 90 days after the procedure, with a possible variation of 15 days before or after this timepoint.
The assessment will use the mRS (modified Rankin Scale), which measures your level of disability or dependence in daily activities.
The scale ranges from 0 (no symptoms) to 6 (death). A score of 0 to 1 indicates an excellent outcome with no significant disability.

Who can join the trial?

8 criteria

You must have an acute ischemic stroke, which is a sudden blockage of blood flow to the brain caused by a blood clot in a large blood vessel at the front part of the brain
The blockage must be confirmed by a brain scan using either CT scan (a type of X-ray that creates detailed pictures of the brain) or MRI (a scan that uses magnets to create images of the brain), and must be verified during the procedure that removes the clot
The blocked blood vessel must be successfully reopened during the clot removal procedure, meaning blood flow has been restored to an adequate level
The time from when your stroke symptoms started, or when you were last known to be well, to the study procedure must be less than 24 hours
You must have been able to function independently before the stroke, with little to no disability in your daily activities
Your stroke symptoms must be moderate to severe, measured by a stroke scale score between 4 and 25 points before the clot removal procedure
You must be 18 years of age or older
Your brain scan must show limited damage to the brain tissue, with a score of 6 or higher on a CT scan or 5 or higher on an MRI scan using a scoring system that measures early stroke damage

Who cannot join the trial?

4 criteria

The study documents do not provide specific exclusion criteria, meaning there is no detailed list of reasons why you cannot participate in this clinical trial available in the provided information.
Generally, clinical trials have exclusion criteria that protect patient safety and ensure the study results are reliable, but these specific details are not included in the available data.
Exclusion criteria typically include factors such as other serious medical conditions, certain medications you may be taking, pregnancy (carrying a baby), or recent participation in other studies, but the exact criteria for this particular study are not specified.
Your doctor will need to review the complete study requirements to determine if you are eligible to participate in this trial for acute ischemic stroke (a condition where blood flow to part of the brain is suddenly blocked).

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Verified sites

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Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Klinikum Nuernberg
Nürnberg, Germany
Verified
Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany

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Investigated drugs

Tenecteplase is a clot-busting medication that helps dissolve blood clots. In this trial, it is given directly into the artery after a procedure to open blocked blood vessels in the brain following a stroke. The goal is to see if this additional treatment improves recovery outcomes for stroke patients.

Tenecteplase

What is already known about the treatment

Tenecteplase – Tenecteplase is a clot-dissolving medication given through injection into a vein or artery that is used to treat acute ischemic stroke, which occurs when a blood clot blocks blood flow to the brain. This medication works by activating a natural substance in the body called plasminogen, which then breaks down into plasmin, an enzyme that dissolves the fibrin proteins holding blood clots together. Tenecteplase belongs to a class of drugs called thrombolytics or "clot busters" and is an approved treatment that has been extensively studied in medical research for restoring blood flow in stroke patients. In this clinical trial, researchers are testing whether delivering tenecteplase directly into the artery after mechanically removing the clot can further improve recovery outcomes for stroke patients.

Investigated diseases

Acute Ischemic Stroke – Acute ischemic stroke occurs when blood flow to a part of the brain is suddenly blocked, usually by a blood clot in an artery. This blockage prevents oxygen and nutrients from reaching brain cells, causing them to begin dying within minutes. The condition typically affects the anterior circulation, which refers to the front part of the brain's blood supply system. Common signs include sudden weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, and loss of balance or coordination. The severity depends on which brain area is affected and how long the blockage lasts. Without restoration of blood flow, the affected brain tissue continues to deteriorate, leading to permanent damage.