NCT06878066 Thrombolysis in Factor Xa-inhibitors Trial
| NCT ID | NCT06878066 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Guri Hagberg |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-03-14 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Håkon Ihle-Hansen, MD, PhD
PRINCIPAL INVESTIGATOR
Dept. of Medicine, Baerum Hospital
Frequently Asked Questions
Who can join the NCT06878066 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06878066 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06878066 currently recruiting?
Yes, NCT06878066 is actively recruiting participants. Contact the research team at guhagb@ous-hf.no for enrollment information.
Where is the NCT06878066 trial being conducted?
This trial is being conducted at Bærum, Norway, Ålesund, Norway, Bergen, Norway, Bergen, Norway and 9 additional locations.
Who is sponsoring the NCT06878066 clinical trial?
NCT06878066 is sponsored by Guri Hagberg. The principal investigator is Håkon Ihle-Hansen, MD, PhD at Dept. of Medicine, Baerum Hospital. The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.