Thrombolysis in Factor Xa-inhibitors Trial

Study acronym: SIFT
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Minor Trial sites expanded: 15 → 21 locations
  2. Minor Study sites: 14 to 15
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 5 of 6 entries
  3. Minor Study sites: 13 to 14v11
  4. Minor Site details revised at 3 of 13 sitesv10
  5. Minor Site details revised at 1 of 13 sitesv9
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  1. Minor Site details revised at 2 of 13 sitesv8
  2. Minor Site details revised at 2 of 13 sitesv7
  3. Minor Site details revised at 3 of 13 sitesv6
  4. Minor Site details revised at 3 of 13 sitesv5
  5. Minor Site details revised at 4 of 13 sitesv4
  6. Minor Secondary endpoints: details revised at 2 of 6 entriesv3
  7. Minor Start date changed from estimate of Mar 11, 2025 to Mar 14, 2025
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description expanded, about 147 words
    v2
  1. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06878066
Lead Sponsor Guri Hagberg
Collaborators: Klinbeforsk, Clinical Trial Unit (CTU), Oslo University Hospital
Conditions
(from sponsor)
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 +1 more
Related terms Intracranial Hemorrhages, Ischemic Stroke, Stroke
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov