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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be 18 years of age or older.

• Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)

• Clinical diagnosis of AIS with disabling neurological deficit

• Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.

• Informed consent

Locations
Other Locations
Norway
Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital
RECRUITING
Ålesund
Dept. of Medicine, Baerum Hospital
RECRUITING
Bærum
Dept of Medicine, Haraldsplass deaconal Hospital
RECRUITING
Bergen
Dept. Of Neurology, Haukeland University Hopsital
RECRUITING
Bergen
Dept of Neurology, Drammen Hospital Trust
RECRUITING
Drammen
Dept of Neurology, Ostfold Hospital Trust, Kalnes
RECRUITING
Grålum
Dept of Neurology, Hospital of Southern Norway, SSHF
RECRUITING
Kristiansand
Dept of Neurology, Innlandet Hospital Trust, Lillehammer
RECRUITING
Lillehammer
Dept. of Neurology, Oslo University Hospital
RECRUITING
Oslo
Dept of Neurology, Stavanger University Hospital
RECRUITING
Stavanger
Dept of Neurology, Vesfold Hospital Trust, Tonsberg
RECRUITING
Tønsberg
Dept. of Neurology, Tromso University Hospital
RECRUITING
Tromsø
Dept. Of Medicine, St.Olav Hospital, Trondheim
RECRUITING
Trondheim
Contact Information
Primary
Guri Hagberg, MD, PhD
guhagb@ous-hf.no
+47 92821843
Backup
Kim L Schultz, MD
kimsch@ous-hf.no
+47 40859583
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2037-12-31
Participants
Target number of participants: 300
Treatments
Active_comparator: IVT
Intravenous Thrombolysis (IVT) with Alteplase or Tenecteplase
No_intervention: NO IVT
Standard Care Without Thrombolysis
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Trial Unit (CTU), Oslo University Hospital, Klinbeforsk
Leads: Guri Hagberg

This content was sourced from clinicaltrials.gov