Tenecteplase for Acute ischemic stroke|Ischemic stroke with recent direct oral anticoagulant ingestion

Inclusion criteria

• {"criterion_text":"- Informed consent (deferred consent when possible according to national legislation)"}
• {"criterion_text":"- AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Either o Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR o 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)."}

Exclusion criteria

• {"criterion_text":"- Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above."}
• {"criterion_text":"- Intended reversal by specific or unspecific reversal agents"}
• {"criterion_text":"- 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 o Age > 55 years OR o Age < 55 years and at least 12 months since last menstrual period OR o Have had a documented surgical sterilization"}
• {"criterion_text":"- Patient < 18 years of age (since the benefit of IVT is unproven in this population)"}
• {"criterion_text":"- Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, we 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: - Intended treatment with endovascular reperfusion strategies"}

Primary endpoints

• {"endpoint_text":"- modified Rankin Scale (mRS, functional outcome) at 90 days ± 2 weeks (shift analysis)","definition_or_measurement_approach":"Functional outcome measured by modified Rankin Scale (mRS) at 90 days ± 2 weeks; analyzed as a shift analysis."}

Secondary endpoints

• {"endpoint_text":"- Dichotomized good functional outcome (mRS 0-2 or return to baseline at day 90 (±2 weeks))","definition_or_measurement_approach":"Dichotomized mRS at day 90 ±2 weeks (mRS 0-2 or return to baseline)."}
• {"endpoint_text":"- change in stroke severity (National Institutes of Health Stroke Scale and ischemic stroke volume) between baseline and 24 ± 12 hours","definition_or_measurement_approach":"Change from baseline to 24 ±12 hours measured by NIH Stroke Scale and ischemic stroke volume."}
• {"endpoint_text":"- health-related Quality of Life (EuroQol 5D-3L) at 90 days ± 2 weeks","definition_or_measurement_approach":"EQ-5D-3L questionnaire at day 90 ±2 weeks."}
• {"endpoint_text":"- symptomatic intracranial hemorrhage within the first 36 hours (European Co-operative Acute Stroke Study-II definition)","definition_or_measurement_approach":"Occurrence of symptomatic intracranial hemorrhage within 36 hours, defined per ECASS-II criteria."}
• {"endpoint_text":"- major extracranial bleeding up to 24 ± 12 hours","definition_or_measurement_approach":"Occurrence of major extracranial bleeding up to 24 ±12 hours (as defined in protocol)."}
• {"endpoint_text":"- all-cause mortality up to 7 days after admission or until discharge","definition_or_measurement_approach":"All-cause mortality assessed up to 7 days after admission or until hospital discharge."}

Primary sponsor

Full Name

Insel Gruppe AG

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Switzerland