Actively Recruiting
The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)
Led by Guri Hagberg · Updated on 2025-09-02
300
Participants Needed
13
Research Sites
469 weeks
Total Duration
On this page
Sponsors
G
Guri Hagberg
Lead Sponsor
K
Klinbeforsk
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether stroke patients who have recently taken Factor Xa (FXa) inhibitors, a type of blood thinner, can safely receive intravenous thrombolysis (IVT), a clot-busting emergency treatment. Current guidelines advise against IVT within 48 hours of FXa inhibitor use due to bleeding risks, but new studies suggest IVT might be safe for these patients. This phase III multicenter trial aims to provide solid evidence on the safety and effectiveness of IVT in this group, potentially changing stroke treatment guidelines to help more patients. Participants are randomly assigned to one of two groups: one receiving IVT with either alteplase or tenecteplase according to hospital procedures, and the other receiving standard care with aspirin but no IVT. The IVT group gets specific doses of the drugs either as an infusion or a single bolus. The study compares early neurological improvement and safety outcomes between these groups. The trial runs from 2025 to 2029, with patient follow-up lasting 90 days. During the study, researchers monitor neurological function using standardized scales such as the NIH Stroke Scale and brain imaging to measure infarct size and bleeding events. They also assess functional outcomes and mortality up to 90 days after treatment. Safety monitoring includes checking for symptomatic brain bleeding within 36 hours. The trial uses a randomized, open-label design with blinded outcome assessment, aiming to enroll 300 patients across multiple centers.
CONDITIONS
Brief 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 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.
- Informed consent obtained.
You will not qualify if you...
- Eligible for endovascular treatment with isolated large vessel occlusion in specific brain arteries with expected fast intervention.
- High blood pressure above 185/110 mmHg despite treatment.
- Known bleeding disorders, recent severe bleeding, or significant bleeding issues in the last 6 months.
- Recent invasive procedures, major surgery, trauma, or obstetrical delivery within defined timeframes.
- History of intracranial hemorrhage, recent stroke or brain surgery, serious head trauma, infections or serious medical illnesses affecting treatment.
- Conditions considered high risk by the treating physician for thrombolysis.
- Use of direct thrombin inhibitor (Dabigatran), warfarin with high INR, recent heparin or low molecular weight heparin treatment.
- Hypersensitivity to alteplase or tenecteplase.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session within 4.5 hours of symptom onset
Participants receive intravenous thrombolysis with either Alteplase or Tenecteplase according to hospital procedures or standard care without thrombolysis.
1 treatment visit (in-person)
Duration - 90 days
Participants are monitored for neurological improvement, brain imaging changes, and safety outcomes including hemorrhage and survival.
Approximately 3 visits including assessments at 24 hours, 36 hours, and 90 days
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
K
Kim L Schultz, MD
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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