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Study on the Effectiveness of Tenecteplase in Patients with Acute Ischemic Stroke Taking Rivaroxaban, Apixaban, or Edoxaban

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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 treatment of acute ischemic stroke, a condition where blood flow to a part of the brain is blocked, leading to potential brain damage. The study will explore the use of Tenecteplase and Alteplase, both of which are medications given through an injection into a vein to help dissolve blood clots. Additionally, the trial will involve patients who have recently taken medications known as Factor Xa inhibitors, which include Rivaroxaban, Apixaban, and Edoxaban. These medications are typically used to prevent blood clots but may complicate treatment in the event of a stroke.

The purpose of the study is to compare the early improvement in neurological function between patients treated with intravenous thrombolysis (a treatment to dissolve clots) within 4.5 hours of stroke onset and those receiving the current standard care. Participants will be monitored for changes in their condition, including improvements in their ability to move and function, as well as any potential side effects. The study will also look at the overall recovery of patients over a period of 90 days.

Participants in the study will receive either the thrombolysis treatment or a placebo, and their progress will be closely observed by medical professionals. The trial aims to provide valuable insights into the effectiveness and safety of using thrombolysis in patients who have taken Factor Xa inhibitors, potentially leading to improved treatment options for those experiencing an acute ischemic stroke.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (18 years or older), recent ingestion of Factor Xa inhibitors (such as rivaroxaban, apixaban, or edoxaban) within the last 48 hours, and a clinical diagnosis of acute ischemic stroke with a disabling neurological deficit.
The assessment also checks if symptoms began within 4.5 hours or if there is a specific MRI finding (FLAIR-DWI mismatch) if symptoms appeared upon waking.
Step 2
Informed consent
Informed consent is obtained, ensuring understanding of the trial's purpose, procedures, and potential risks and benefits.
Step 3
Treatment allocation
Participants are allocated to receive either intravenous thrombolysis (IVT) or the current standard of care. IVT involves the administration of tenecteplase or alteplase through an intravenous route.
Step 4
Treatment administration
If assigned to IVT, the medication is administered within 4.5 hours of stroke onset. The specific dosage and duration are determined by the medical team based on individual needs.
Step 5
Monitoring and evaluation
Participants are monitored for early neurological improvement, defined as a significant reduction in stroke severity within 24 hours. This is measured using the National Institutes of Health Stroke Scale (NIHSS).
Additional evaluations include changes in stroke severity and brain infarct volume, as well as the occurrence of any bleeding complications or other adverse events.
Step 6
Follow-up assessments
Follow-up assessments occur at various intervals, including 24 hours, 36 hours, and 90 days post-treatment. These assessments evaluate functional outcomes, any complications, and overall recovery.

Who can join the trial?

5 criteria

Participant must be 18 years of age or older.
Must have taken FXa inhibitors within the last 48 hours of symptom onset, or have an ongoing prescription if the exact time is unknown. FXa inhibitors are medications that help prevent blood clots.
Must have a clinical diagnosis of acute ischemic stroke (AIS) with a disabling neurological deficit. This means the stroke is caused by a blockage in a blood vessel in the brain, leading to significant problems with movement, speech, or other functions.
Must arrive at the hospital within 4.5 hours of symptom onset, or after waking up with symptoms of AIS. An MRI scan must show a FLAIR-DWI mismatch, which is a specific pattern seen on the scan that helps doctors understand the stroke better.
Must provide informed consent, meaning the participant agrees to join the study after understanding all the details and risks involved.

Who cannot join the trial?

6 criteria

Patients who have had a recent **acute ischemic stroke**. This is a type of stroke where blood flow to a part of the brain is blocked.
Patients who are not within the age range specified for the study. The study may have specific age requirements.
Patients who are not taking **FXa inhibitors**. These are medications that help prevent blood clots.
Patients who cannot receive **IVT** treatment within 4.5 hours after the stroke starts. IVT is a treatment that involves giving medicine through a vein to dissolve blood clots.
Patients who are not part of the specific clinical trial group required for the study.
Patients who are part of a vulnerable population that the study does not include. This could mean people who need special protection or care.

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Verified sites

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

Verified
Aalborg University Hospital
Aalborg, Denmark
Responsive
Sykehuset I Vestfold HF
Tonsberg, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway

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Investigated drugs

Intravenous Thrombolysis (IVT)
is a treatment used to dissolve blood clots in patients who have had an acute ischemic stroke. This therapy is administered through a vein and aims to restore blood flow to the brain, potentially improving neurological outcomes if given within a specific time window after stroke onset.
Factor Xa Inhibitors
are a type of medication that helps prevent blood clots by inhibiting a specific part of the blood clotting process. These medications are often used in patients to reduce the risk of stroke and other clot-related conditions. In this trial, the focus is on patients who have recently taken these inhibitors and are experiencing an acute ischemic stroke.

What is already known about the treatment

Intravenous Thrombolysis – This medication is administered through an intravenous injection and is currently being studied in clinical trials for its effectiveness in treating acute ischemic stroke. It is primarily used to dissolve blood clots that block blood flow to the brain, aiming to improve neurological outcomes when given within 4.5 hours of stroke onset. The mechanism of action involves breaking down fibrin, a protein involved in clot formation, thereby restoring blood flow. It is classified as a thrombolytic agent and is being compared to standard care in patients who have recently taken Factor Xa inhibitors.

Investigated diseases

Acute Ischemic Stroke – This condition occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. The lack of oxygen causes brain cells to begin dying within minutes. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, vision problems, dizziness, and loss of balance or coordination. The progression of the disease can lead to significant neurological impairment if not addressed promptly. The severity and specific symptoms depend on the location and extent of the blockage in the brain. Early intervention is crucial to minimize brain damage and improve outcomes.