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NCT06878066RecruitingPhase 3

Thrombolysis in Factor Xa-inhibitors Trial

The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
300 (estimated)
First submitted
10 Mar 2025
Start date
14 Mar 2025
Primary completion date
31 Dec 2028
Lead sponsor
Guri Hagberg
NCT number
NCT06878066
EU CT number
2023-509907-34-01

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 300
  • From 14 Mar 2025 to the primary completion date, 31 Dec 2028
  • 30 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

  • 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

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sygehus Sønderjylland, Aabenraa
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AabenraaDenmarkRecruiting
Aalborg Universitetshospital
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AalborgDenmarkRecruiting
Aarhus Universitethospital
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Aarhus NDenmarkRecruiting
Rigshospitalet
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GlostrupDenmarkRecruiting
Regionshospitalet Gødstrup
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HerningDenmarkRecruiting
Bispebjerg Hospital, Region Hovedstaden
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KøbenhavnDenmarkRecruiting
Sygehus Lillebælt, Region Syddanmark
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KoldingDenmarkRecruiting
Odense Universitetshospital
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OdenseDenmarkRecruiting
Sjællands Universitetshospital
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RoskildeDenmarkRecruiting
Helse Møre and Romsdal Health Trust
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ÅlesundNorwayRecruiting
Haukeland University Hospital
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BergenNorwayRecruiting
Haraldsplass Diakonale Sykehus AS
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BergenNorwayRecruiting
Drammen Sykehus
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DrammenNorwayRecruiting
Vestre Viken HF
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GjettumNorwayRecruiting
Østfold Hospital Trust
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GrålumNorwayRecruiting
Sykehuset Innlandet
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LillehammerNorwayRecruiting
Helse Møre og Romsdal Hospital Trust
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MoldeNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Sykehuset Telemark HF
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SkienNorwayRecruiting
Helse Stavanger HF
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StavangerNorwayRecruiting
Sykehuset I Vestfold HF
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TonsbergNorwayRecruiting
University Hospital of North Norway
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TromsøNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Hospital of Southern Norway, Kristiansand
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-NorwayRecruiting
Danderyds Sjukhus AB
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DanderydSwedenRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Region Skane Skanes Universitetssjukhus
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MalmoSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Norrlands universitetssjukhus
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UmeåSwedenRecruiting
Uppsala University Hospital
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UppsalaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.