RecruitingPhase 3NCT06878066

Thrombolysis in Factor Xa-inhibitors Trial

The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)


Sponsor

Guri Hagberg

Enrollment

300 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT). IVT is a common emergency treatment for stroke, but current guidelines say it should not be given to people who have taken FXa inhibitors in the last 48 hours. This is because doctors worry that IVT might cause dangerous bleeding in the brain. However, new research suggests that IVT might be safe for these patients. Some studies even show that stroke patients on FXa inhibitors who receive IVT do not have a higher risk of brain bleeding than other stroke patients. But because these studies were not designed as full medical trials, doctors still avoid IVT for this group. The SIFT trial will compare two groups of stroke patients who take FXa inhibitors: One group will receive IVT to see if it helps them recover better. One group will not receive IVT, which is the current standard. Doctors will check if IVT helps with recovery and if it causes any serious bleeding. If IVT is found to be safe and effective, this study could change stroke treatment guidelines and help more patients get life-saving care. Right now, some guidelines say that stroke patients on FXa inhibitors should have a blood test before getting IVT, to measure how much of the drug is in their system. But these tests are not available in most hospitals, and waiting for results could delay important treatment. The SIFT trial will not require this test before giving IVT. More and more people use FXa inhibitors to prevent strokes, but right now, they are being denied IVT based on old rules. If this study proves that IVT is safe for them, it could help doctors give better care to thousands of stroke patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether it is safe and effective to give clot-busting therapy (thrombolysis) to patients having an acute ischemic stroke (a stroke caused by a blood clot blocking a brain artery) who are taking factor Xa inhibitor blood thinners such as rivaroxaban or apixaban. **You may be eligible if...** - You are 18 or older - You have taken a factor Xa inhibitor blood thinner (such as apixaban or rivaroxaban) within the last 48 hours of stroke symptoms starting - You have been diagnosed with an acute ischemic stroke causing disabling neurological symptoms - You are presenting within 4.5 hours of symptom onset, or woke up with stroke symptoms and have a specific MRI pattern (FLAIR-DWI mismatch) **You may NOT be eligible if...** - You have a large vessel occlusion in a major brain artery that is better treated with a mechanical procedure to remove the clot - You have contraindications to thrombolysis (clot-busting drugs) - You have had a recent major surgery, severe bleeding, or other standard exclusions for stroke thrombolysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGthrombolysis therapy

All treatment and monitoring routines are according to the hospitals' standard operating procedures (SOP), and both drugs (Alteplase (ALP) and Tenecteplase (TNK)) are approved drugs for the indication AIS with similar efficacy and safety profile. SIFT is designed to test the hypothesis that intravenous thrombolysis (IVT) (tenecteplase 0.25 mg/kg or alteplase 0.9 mg/kg intravenously) is efficient and safe in acute ischemic stroke patients (AIS) with recent ingestion (last 48 hours) of an Factor Xa (FXa) inhibitor who otherwise are eligible for IVT.


Locations(13)

Dept. of Medicine, Baerum Hospital

Bærum, Gjettum, Norway

Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital

Ålesund, Norway

Dept of Medicine, Haraldsplass deaconal Hospital

Bergen, Norway

Dept. Of Neurology, Haukeland University Hopsital

Bergen, Norway

Dept of Neurology, Drammen Hospital Trust

Drammen, Norway

Dept of Neurology, Ostfold Hospital Trust, Kalnes

Grålum, Norway

Dept of Neurology, Hospital of Southern Norway, SSHF

Kristiansand, Norway

Dept of Neurology, Innlandet Hospital Trust, Lillehammer

Lillehammer, Norway

Dept. of Neurology, Oslo University Hospital

Oslo, Norway

Dept of Neurology, Stavanger University Hospital

Stavanger, Norway

Dept. of Neurology, Tromso University Hospital

Tromsø, Norway

Dept. Of Medicine, St.Olav Hospital, Trondheim

Trondheim, Norway

Dept of Neurology, Vesfold Hospital Trust, Tonsberg

Tønsberg, Norway

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NCT06878066


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