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Study on the Safety and Effectiveness of Tenecteplase for Patients with Acute Ischemic Stroke and Incomplete Reperfusion After Mechanical 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

This clinical trial is focused on studying the safety and effectiveness of a treatment for acute ischemic stroke, a condition where blood flow to the brain is blocked, often by a clot. The treatment being tested is called Tenecteplase, also known by its code name TNK-TPA. This medication is administered directly into the arteries to help dissolve clots in patients who have experienced a stroke due to a blockage in a large blood vessel, and who have not achieved complete blood flow restoration after a procedure called mechanical thrombectomy.

The purpose of the study is to determine how safe and effective Tenecteplase is for patients with this type of stroke. Participants in the study will receive either the medication or a placebo. The study will monitor the early and late restoration of blood flow in the brain, as well as the degree of disability or dependence after 90 days. Other aspects being observed include changes in stroke severity, quality of life, and overall survival at 90 days.

The study will follow participants over a period of time to assess these outcomes. The goal is to gather information that could help improve treatment options for people who experience an acute ischemic stroke with incomplete blood flow restoration after initial treatment. This research is important for understanding how to better manage and treat this serious condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This means understanding the study's purpose, procedures, and potential risks and benefits before agreeing to participate.
Eligibility criteria include being at least 18 years old and experiencing clinical signs consistent with an acute ischemic stroke.
Step 2
Initial assessment
An initial assessment will be conducted to confirm the presence of a large vessel blockage in the brain's anterior circulation. This includes specific areas such as the intracranial ICA, M1, M2, M3, A1, A2, P1, or P2.
The assessment will also confirm that the patient has undergone a procedure called endovascular stroke treatment.
Step 3
Randomization
Randomization will occur within 705 minutes (11 hours and 45 minutes) after the onset of stroke symptoms or the last time the patient was known to be well.
This step involves being randomly assigned to receive the study treatment or a standard treatment.
Step 4
Treatment administration
The study treatment involves the administration of tenecteplase, a medication given through intra-arterial use. This means it is delivered directly into the artery.
The medication is provided as a solution for injection, specifically Metalyse 10,000 units.
Step 5
Monitoring and follow-up
After treatment, monitoring will occur to assess early and late reperfusion, which refers to the restoration of blood flow in the brain.
Follow-up assessments will be conducted to evaluate the degree of disability or dependence at approximately 90 days, using a scale called the mRS.
Additional evaluations include changes in the NIHSS, a scale that measures stroke severity, at 24 hours and 90 days post-randomization.
Quality of life will be assessed using the EuroQol 5D-3L questionnaire at 90 days, and all-cause mortality will be recorded at 90 days.

Who can join the trial?

10 criteria

Provide informed consent, which means you agree to participate after understanding the study details.
Be at least 18 years old.
Show clinical signs that match an acute ischemic stroke, which is a type of stroke caused by a blockage in a blood vessel in the brain.
Have had an initial blockage in a large blood vessel in the front part of the brain, specifically in areas called intracranial ICA, M1, M2, M3, A1, A2, P1, or P2.
Have undergone a procedure called endovascular stroke treatment, which is a treatment to remove the blockage in the blood vessel.
Be randomized to the study within 705 minutes (11 hours and 45 minutes) after the stroke symptoms started or were last known to be well.
Have incomplete reperfusion, meaning the blood flow was not fully restored after treatment. This is defined as:
- For ICA/M1: TICI2b/2c (50-99%) reperfusion after treatment without a blockage that can be fixed mechanically.
- For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after treatment without a blockage that can be fixed mechanically.
- Any new blockages in other areas without a blockage that can be fixed mechanically.
- Show signs of early changes in the brain due to the stroke on a CT scan, with an ASPECTS score of 5 or more. This score helps doctors assess the extent of the stroke.

Who cannot join the trial?

8 criteria

Patients who have had a recent major surgery or serious injury.
Patients with a history of bleeding disorders, which means their blood does not clot properly.
Patients who are currently taking blood-thinning medications, which are drugs that prevent blood clots.
Patients with uncontrolled high blood pressure, meaning their blood pressure is too high and not managed by medication.
Patients who have had a previous stroke within the last three months.
Patients with severe liver or kidney disease, which means their liver or kidneys are not working properly.
Patients who are pregnant or breastfeeding.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

Trial locations

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Investigated drugs

Tenecteplase is a medication used in this clinical trial to help treat patients who have had a stroke. A stroke can happen when a blood clot blocks a blood vessel in the brain, stopping blood from getting to that part of the brain. This medication is given directly into the arteries to help dissolve the blood clot and improve blood flow. The goal is to see if this medication is safe and effective for patients who have had a stroke and still have some blockage in their brain's blood vessels even after another procedure called mechanical thrombectomy, which is used to remove clots. By using this medication, doctors hope to improve recovery and outcomes for stroke patients.

Tenecteplase

What is already known about the treatment

Tenecteplase – Tenecteplase is administered directly into the arteries, a method known as intra-arterial administration, to treat patients who have had an acute ischemic stroke with incomplete blood flow restoration. This medication is currently being studied in clinical trials to assess its safety and effectiveness for this specific condition. It is primarily used to help dissolve blood clots in the brain, which can improve blood flow and reduce damage during a stroke. At the molecular level, Tenecteplase works by breaking down the proteins in blood clots, helping to restore normal blood circulation. It is classified as a thrombolytic agent, which means it is a type of medication that helps dissolve clots.

Investigated diseases

Acute Ischemic Stroke – Acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a sudden loss of blood flow. This interruption in blood supply results in the deprivation of oxygen and nutrients to brain tissue, leading to the death of brain cells. The progression of the disease can vary, but it often begins with sudden symptoms such as weakness or numbness on one side of the body, confusion, trouble speaking, or difficulty seeing. If the blockage is not quickly resolved, more brain tissue can be affected, potentially leading to more severe neurological deficits. In some cases, partial reperfusion may occur, where blood flow is partially restored, but residual occlusions remain, which can continue to affect brain function. The extent of recovery or progression depends on the location and size of the affected area and the timeliness of medical intervention.