Thrombolysis in Factor Xa-inhibitors Trial

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.

Conditions

• Stroke
• Stroke (in Patients With Atrial Fibrillation)
• Ischemic Stroke
• Acute Ischemic Stroke
• Anticoagulant Therapy
• Factor Xa Inhibitor
• Intracranial Hemorrhages
• Hemorrhagic Transformation Due to Acute Stroke
• Bleeding in the Brain

Interventions

DRUG

thrombolysis 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.

Sponsors & Collaborators

• Klinbeforsk

  collaborator OTHER

• Clinical Trial Unit (CTU), Oslo University Hospital

  collaborator UNKNOWN

• Guri Hagberg

  lead OTHER

Principal Investigators

• Håkon Ihle-Hansen, MD, PhD · Dept. of Medicine, Baerum Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-14

Primary Completion

2028-12-31

Completion

2037-12-31

Countries

• Norway

Study Locations