Thrombolysis in Factor Xa-inhibitors Trial

Launched by GURI HAGBERG · Mar 10, 2025

Keywords

ClinConnect Summary

The Thrombolysis in Factor Xa-inhibitors Trial, or SIFT trial, is studying whether stroke patients who have taken a blood thinner called FXa inhibitors can safely receive a treatment known as IVT, which is designed to dissolve blood clots during a stroke. Currently, guidelines suggest that patients who have taken FXa inhibitors in the last 48 hours should not receive IVT due to concerns about potential bleeding in the brain. However, some recent studies indicate that IVT may be safe for these patients, and the SIFT trial aims to provide clearer answers.

To participate in this trial, individuals must be 18 years or older, have taken FXa inhibitors within the last 48 hours, and be diagnosed with an acute ischemic stroke that causes a significant neurological deficit. Participants will be divided into two groups: one will receive IVT, while the other will receive standard care without IVT. The trial will monitor how well IVT helps with recovery and whether it leads to serious bleeding. Importantly, the trial does not require a blood test to check FXa inhibitor levels before administering IVT, which could speed up treatment. If the trial shows that IVT is safe for these patients, it could change how strokes are treated, offering life-saving options to many more people.

Gender

ALL

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