Safety and Tolerability of AZD6482 in Reperfusion for Stroke (STARS) Study
Lead PI: Dr Candice Delcourt
Status: Recruiting
No. of patients currently recruited: 0
No. of patients required: 80
The STARS Study is a multicentre, open-label, dose escalation, phase IIa study to assess the safety and tolerability of AZD6482, an antiplatelet agent, in patients with acute ischaemic stroke. AZD6482 is an intravenous PI3Kβ inhibitor which blocks platelet activation, adhesion/aggregation and promotes platelet disaggregation. It has been shown to effectively inhibit thrombosis without interfering with normal haemostasis. Four dose levels will be administered using a serial dose-escalation design in addition to standard of care (IVT +/- EVT). The primary endpoint of is the proportion of patients with symptomatic ICH within 24-36 hours of study drug commencement. sICH will be defined as parenchymal haemorrhage type II (Heidelberg Classification) or any ICH leading to an increase in NIHSS of 4 points or more. As safety criteria are satisfied, based on ICH rates, dose escalation will proceed using the continual reassessment method.
