Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial

Condition studied

acute ischemic stroke

Investigational medicinal product(s)

Eligibility

Primary endpoint

Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation

Endpoint detail

Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days, Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days, Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours, Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days, Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days, Safety Endpoint: Any intracranial haemorrhage within 36 hours, Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST), Safety Endpoint: Fatal intracranial haemorrhage within 30 days, Safety Endpoint: Major haemorrhage (ISTH) within 72 hours, Safety Endpoint: Orolingual angioedema within 4 hours, Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days, Safety Endpoint: All-cause mortality after 90 days, Safety Endpoint: Time to death right-censored at 90 days