Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake

Prior treatment

• Intended treatment with endovascular reperfusion strategies

Age

• Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria
  • Age \> 55 years OR
  • Age \< 55 years and at least 12 months since last menstrual period OR
  • Have had a documented surgical sterilization
• Patient \< 18 years of age (since the benefit of IVT is unproven in this population)
  • Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:

Other

• Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
• Intended reversal by specific or unspecific reversal agents

• Informed consent (deferred consent when possible according to national legislation)
• AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
• DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
• Either
  • Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
  • MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).