Thrombolysis for stroke patients on Factor Xa inhibitors
The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)
This study is testing if a common stroke treatment can safely help patients who have taken certain blood thinners in the last two days.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 13 sites (Bærum, Gjettum and 12 other locations) |
| Trial ID | NCT06878066 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of intravenous thrombolysis (IVT) in patients with acute ischemic stroke (AIS) who have taken Factor Xa inhibitors within the last 48 hours. It aims to challenge current guidelines that prohibit IVT for these patients due to concerns about bleeding risks. The study will compare outcomes between two groups: one receiving IVT and the other receiving standard care without IVT. By utilizing a pragmatic, multicenter approach, the trial seeks to provide robust evidence on the potential benefits of IVT in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke and have taken Factor Xa inhibitors within the last 48 hours.
Not a fit: Patients with isolated large vessel occlusion or significant bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable safer treatment options for stroke patients on Factor Xa inhibitors, potentially improving recovery outcomes.
How similar studies have performed: Previous observational studies suggest that IVT may be safe for patients on Factor Xa inhibitors, but this trial is necessary to provide definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant must be 18 years of age or older. 2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown) 3. Clinical diagnosis of AIS with disabling neurological deficit 4. 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. 5. Informed consent Exclusion Criteria: 1. 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. 2. Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment. 3. Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months. 4. 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. 5. 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 6. 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 7. Hypersensitivity to Alteplase or Tenecteplase
Where this trial is running
Bærum, Gjettum and 12 other locations
- Dept. of Medicine, Baerum Hospital — Bærum, Gjettum, Norway (Recruiting)
- Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital — Ålesund, Norway (Recruiting)
- Dept of Medicine, Haraldsplass deaconal Hospital — Bergen, Norway (Recruiting)
- Dept. Of Neurology, Haukeland University Hopsital — Bergen, Norway (Recruiting)
- Dept of Neurology, Drammen Hospital Trust — Drammen, Norway (Recruiting)
- Dept of Neurology, Ostfold Hospital Trust, Kalnes — Grålum, Norway (Recruiting)
- Dept of Neurology, Hospital of Southern Norway, SSHF — Kristiansand, Norway (Recruiting)
- Dept of Neurology, Innlandet Hospital Trust, Lillehammer — Lillehammer, Norway (Recruiting)
- Dept. of Neurology, Oslo University Hospital — Oslo, Norway (Recruiting)
- Dept of Neurology, Stavanger University Hospital — Stavanger, Norway (Recruiting)
- Dept. of Neurology, Tromso University Hospital — Tromsø, Norway (Recruiting)
- Dept. Of Medicine, St.Olav Hospital, Trondheim — Trondheim, Norway (Recruiting)
- Dept of Neurology, Vesfold Hospital Trust, Tonsberg — Tønsberg, Norway (Recruiting)
Study contacts
- Principal investigator: Håkon Ihle-Hansen, MD, PhD — Dept. of Medicine, Baerum Hospital
- Study coordinator: Guri Hagberg, MD, PhD
- Email: guhagb@ous-hf.no
- Phone: +47 92821843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.