Tests clot-busting treatment in stroke patients taking factor Xa inhibitors
Compares clot-busting treatment with no treatment in adult stroke patients taking blood thinners.
Key facts
- Who runs it
- Guri Hagberg
- Where
- Ålesund, Bergen, Drammen, Gjettum, Grålum, Lillehammer, Molde, Oslo, Skien, Stavanger, Tonsberg, Tromsø, and Trondheim, NorwaySee the 15 sitesAlso in 2 other countries, 15 sites
- Trial code
- Registry title
- Thrombolysis in Factor Xa-inhibitors Trial
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 300 people, planned
- Started
- 14 Mar 2025
- Expected to end
- 31 Dec 2037
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- thrombolysis therapy
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having an acute ischemic stroke who recently took a factor Xa inhibitor blood thinner. It tests whether clot-busting treatment (IVT) is safe and helps recovery.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with a disabling neurological deficit, seen within 4.5 hours of symptom start, or after waking with symptoms and a FLAIR-DWI mismatch on MRI.
- Earlier treatment
- Must have taken a factor Xa inhibitor within the last 48 hours before symptoms started, or be on one with an unknown last dose. Cannot have taken dabigatran, warfarin with an INR of 1.8 or more, heparin in the last 48 hours, or a treatment dose of LMWH in the last 24 hours.
Main reasons for not taking part
- Blood pressure above 185 mmHg systolic or 110 mmHg diastolic despite treatment
- Known bleeding disorder or recent serious bleeding
- Past bleeding in the brain, or a stroke or serious head injury in the last 2 months
- Major surgery or serious trauma in the last 14 days
- Allergy to Alteplase or Tenecteplase
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Hypersensitivity to Alteplase or Tenecteplase
- 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
- 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
Where in Norway
Also in 2 other countries, 15 sites
- Hospital of Southern Norway, KristiansandNorwayTaking people
- Helse Møre and Romsdal Health TrustÅlesund, NorwayTaking people
- Haraldsplass Diakonale Sykehus ASBergen, NorwayTaking people
- Haukeland University HospitalBergen, NorwayTaking people
- Drammen SykehusDrammen, NorwayTaking people
- Vestre Viken HFGjettum, NorwayTaking people
- Østfold Hospital TrustGrålum, NorwayTaking people
- Sykehuset InnlandetLillehammer, NorwayTaking people
- Helse Møre og Romsdal Hospital TrustMolde, NorwayTaking people
- Oslo University Hospital HFOslo, NorwayTaking people
- Sykehuset Telemark HFSkien, NorwayTaking people
- Helse Stavanger HFStavanger, NorwayTaking people
- Sykehuset I Vestfold HFTonsberg, NorwayTaking people
- University Hospital of North NorwayTromsø, NorwayTaking people
- St. Olavs hospital HFTrondheim, NorwayTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- IVTExisting treatment, for comparison
Intravenous Thrombolysis (IVT) with Alteplase or Tenecteplase
Treatment: thrombolysis therapy
- NO IVTNo study treatment, for comparison
Standard Care Without Thrombolysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)
- Plain-language title
- Tests clot-busting treatment in stroke patients taking factor Xa inhibitorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 November 2026