Status:
RECRUITING
Thrombolysis in Factor Xa-inhibitors Trial
Lead Sponsor:
Guri Hagberg
Collaborating Sponsors:
Klinbeforsk
Clinical Trial Unit (CTU), Oslo University Hospital
Conditions:
Stroke
Stroke (in Patients With Atrial Fibrillation)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 curre...
Detailed Description
The SIFT trial is a pragmatic phase III, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE), registry-linked trial. It is designed to test the hypothesis that intravenous throm...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of \<30 minutes.
- Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment.
- Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.
- Arterial puncture at a non-compressible site; biopsy or lumbar puncture \<7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma \<14 days; history of intracranial haemorrhage; stroke \<2 months, CNS neurosurgery \<2 months; serious head trauma \<2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease.
- Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory).
- Prior/Concomitant Therapy
- Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \<48 h; d) treatment dose of LMWH \<24 h.
- Prior/Concurrent Clinical Study Experience
- Hypersensitivity to Alteplase or Tenecteplase
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2037
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06878066
Start Date
March 14 2025
End Date
December 31 2037
Last Update
September 2 2025
Active Locations (13)
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1
Dept. of Medicine, Baerum Hospital
Bærum, Gjettum, Norway, 1346
2
Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital
Ålesund, Norway, 6017
3
Dept of Medicine, Haraldsplass deaconal Hospital
Bergen, Norway, 5009
4
Dept. Of Neurology, Haukeland University Hopsital
Bergen, Norway, 5009