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

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What is this study about?

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.

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.

2 informed consent

Informed consent is obtained, ensuring understanding of the trial’s purpose, procedures, and potential risks and benefits.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Drammen Sykehus	Drammen	Norway
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Sjællands Universitetshospital	Roskilde	Denmark
Odense University Hospital	Odense	Denmark
Vestre Viken HF	Drammen	Norway
Karolinska University Hospital	Solna	Sweden
Lillebaelt Hospital	Kolding	Denmark
Aalborg University Hospital	Aalborg	Denmark
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Rigshospitalet	Copenhagen	Denmark
Sygehus Soenderjylland Soenderborg	Aabenraa	Denmark
Sykehuset I Vestfold HF	Tonsberg	Norway
Helse Møre and Romsdal Health Trust	Aalesund	Norway
Hlhhhawwjunv Dwmabpqxc Sjsuatk Ay	Bergen	Norway
Nzhojspbx uwubxfhahnzwttjmcpi	Umea	Sweden
Uqlkhgk Ufsgiixxdt Hacvstjn	Uppsala	Sweden
Hgmib Bwyexj Hn	Bergen	Norway
Azaoeq Ugxsargixn Hyumkyau	Aarhus	Denmark
Raggnz Meckkvatknn	Herning	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.11.2024
Norway	Recruiting	01.11.2024
Sweden	Not yet recruiting	01.11.2024

Trial locations

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.

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.

Trial ID:

2023-509907-34-01

Protocol code:

SIFT

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?