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
- Diseases
- Stroke, Atrial fibrillation
- 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
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sygehus Sønderjylland, Aabenraa Coordinator of this site? Confirm its status | Aabenraa | Denmark | Recruiting |
| Aalborg Universitetshospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus Universitethospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Recruiting |
| Regionshospitalet Gødstrup Coordinator of this site? Confirm its status | Herning | Denmark | Recruiting |
| Bispebjerg Hospital, Region Hovedstaden Coordinator of this site? Confirm its status | København | Denmark | Recruiting |
| Sygehus Lillebælt, Region Syddanmark Coordinator of this site? Confirm its status | Kolding | Denmark | Recruiting |
| Odense Universitetshospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Sjællands Universitetshospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Helse Møre and Romsdal Health Trust Coordinator of this site? Confirm its status | Ålesund | Norway | Recruiting |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Haraldsplass Diakonale Sykehus AS Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Drammen Sykehus Coordinator of this site? Confirm its status | Drammen | Norway | Recruiting |
| Vestre Viken HF Coordinator of this site? Confirm its status | Gjettum | Norway | Recruiting |
| Østfold Hospital Trust Coordinator of this site? Confirm its status | Grålum | Norway | Recruiting |
| Sykehuset Innlandet Coordinator of this site? Confirm its status | Lillehammer | Norway | Recruiting |
| Helse Møre og Romsdal Hospital Trust Coordinator of this site? Confirm its status | Molde | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Sykehuset Telemark HF Coordinator of this site? Confirm its status | Skien | Norway | Recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| Sykehuset I Vestfold HF Coordinator of this site? Confirm its status | Tonsberg | Norway | Recruiting |
| University Hospital of North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Hospital of Southern Norway, Kristiansand Coordinator of this site? Confirm its status | - | Norway | Recruiting |
| Danderyds Sjukhus AB Coordinator of this site? Confirm its status | Danderyd | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Norrlands universitetssjukhus Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.