Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (OPTIMISTmain): an international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial

Background: The universally accepted best practice protocol for monitoring patients who receive intravenous thrombolysis for acute ischaemic stroke was established in the 1990s. However, the protocol is burdensome for nurses, disrupts the sleep of patients, and is potentially less relevant in patients at low risk of symptomatic intracerebral haemorrhage. We aimed to assess whether implementing a low-intensity monitoring protocol would be as safe and effective as standard high-intensity monitoring for patients with acute ischaemic stroke at low risk. Methods: OPTIMISTmain was an international, pragmatic, multicentre, stepped-wedge, cluster-randomised, controlled, non-inferiority, blinded-endpoint trial conducted at hospitals (clusters) in eight countries. It was designed to test the non-inferiority of a low-intensity monitoring protocol to a standard protocol among consecutive adults with acute ischaemic stroke who were clinically stable with mild to moderate neurological impairment (score </p