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 |
Trial Parameters
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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;
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