Abstract Body: Background: Albumin (ALB) is a multifunctional plasma protein that is mainly synthesised in the liver and also suggested to play a role in a large number of diseases such as cerebral edema and acute ischemic stroke (AIS). Although the specific molecular mechanism of action of ALB is unknown, the efficacy of ALB has been demonstrated in preclinical studies from several models that ALB could act on complex pathophysiological cascade of ischemia. In a multicenter, phase 3 clinical trial testing the efficacy of ALB for AIS patients, ALB did not show clinical benefit. In this trial, only 21% of subjects received endovascular treatment (EVT). However, in recent years, the number of patients worldwide benefiting from EVT has been increasing. And, the Stroke Therapy Academic Industry Round Table X recommended that future clinical studies should make EVT as an inclusion criterion. However, there are no studies on ALB included patients totally receiving EVT, leaving a research gap of whether ALB works better combined with EVT.
Objective: The ARISE trial (NCT06538844) aim to investigate whether treatment with ALB adjunctive to EVT could reduce the infarct volume and improve the functional outcome for AIS patients.
Methods: ARISE is an investigator-initiated, multicentre, double-blind, placebo-controlled, randomized, phase 2 study. We will recruit 134 patients who aged 18-80 years, had AIS due to large vessel occlusion in the anterior circulation within 24 hours from symptom onset, had an Alberta Stroke Program Early CT Score of 3 to 10, and had infarct core volume on baseline less than 100 mL.
Interventions: Patients are randomly assigned, in a 1:1 ratio, to undergoing EVT and receive albumin therapy (0.5g/kg estimated body weight; intravenously injection) or to undergoing EVT and receive placebo therapy (equivalent volume of isotonic saline) once daily for 4 days
Study outcomes: The primary efficacy outcome was the change in infarct volume relative from baseline to day 5.
Trial Status: By Octorber 27, 2024, 69 patients have been enrolled.
Analysis: The ARISE trial will provide valuable evidence on the efficacy and safety of ALB in patients with AIS receiving EVT.