Actively Recruiting
Thrombolysis in Factor Xa-inhibitors Trial
Led by Guri Hagberg · Updated on 2025-09-02
300
Participants Needed
13
Research Sites
667 weeks
Total Duration
On this page
Sponsors
G
Guri Hagberg
Lead Sponsor
K
Klinbeforsk
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Thrombolysis in Factor Xa-inhibitors Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older.
- Ingestion of FXa inhibitors within the last 48 hours of symptom onset or ongoing prescription if timing is unknown.
- Clinical diagnosis of acute ischemic stroke with disabling neurological deficit.
- Presenting within 4.5 hours of symptom onset or after awakening with symptoms confirmed by MRI showing FLAIR-DWI mismatch.
- Informed consent provided.
You will not qualify if you...
- Eligible for endovascular treatment due to isolated large vessel occlusion in internal carotid artery or middle cerebral artery with expected groin puncture within 30 minutes.
- Systolic blood pressure above 185 mmHg or diastolic blood pressure above 110 mmHg despite treatment.
- Known bleeding disorders, recent or severe bleeding, or significant bleeding condition in the last 6 months.
- Recent arterial puncture at non-compressible site, biopsy, lumbar puncture within 7 days; major surgery, trauma, or delivery within 14 days; history of brain hemorrhage or stroke within 2 months; recent neurosurgery or serious head trauma within 2 months; active infections like sepsis or pericarditis; pancreatitis; cancers with bleeding risk; serious medical illnesses likely to interfere with treatment.
- Conditions judged by the physician to increase risk with thrombolysis, including signs of brain hemorrhage or large early ischemic changes on CT.
- Use of direct thrombin inhibitor (dabigatran), warfarin with INR ≥1.8, heparin within 48 hours, or treatment dose low molecular weight heparin within 24 hours.
- Known allergy to alteplase or tenecteplase.
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Dept. of Medicine, Baerum Hospital
Bærum, Gjettum, Norway, 1346
Actively Recruiting
2
Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital
Ålesund, Norway, 6017
Actively Recruiting
3
Dept of Medicine, Haraldsplass deaconal Hospital
Bergen, Norway, 5009
Actively Recruiting
4
Dept. Of Neurology, Haukeland University Hopsital
Bergen, Norway, 5009
Actively Recruiting
5
Dept of Neurology, Drammen Hospital Trust
Drammen, Norway, 3004
Actively Recruiting
6
Dept of Neurology, Ostfold Hospital Trust, Kalnes
Grålum, Norway, 1714
Actively Recruiting
7
Dept of Neurology, Hospital of Southern Norway, SSHF
Kristiansand, Norway, 4615
Actively Recruiting
8
Dept of Neurology, Innlandet Hospital Trust, Lillehammer
Lillehammer, Norway, 2609
Actively Recruiting
9
Dept. of Neurology, Oslo University Hospital
Oslo, Norway, 0450
Actively Recruiting
10
Dept of Neurology, Stavanger University Hospital
Stavanger, Norway, 4011
Actively Recruiting
11
Dept. of Neurology, Tromso University Hospital
Tromsø, Norway, 9019
Actively Recruiting
12
Dept. Of Medicine, St.Olav Hospital, Trondheim
Trondheim, Norway, 7030
Actively Recruiting
13
Dept of Neurology, Vesfold Hospital Trust, Tonsberg
Tønsberg, Norway, 3103
Actively Recruiting
Research Team
G
Guri Hagberg, MD, PhD
CONTACT
K
Kim L Schultz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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