[Fortelyzin for acute ischaemic stroke treatment: an open, prospective, non-interventional, observational study FORPI...

To evaluate safety and efficacy outcomes of Fortelyzin in AIS patients in the FORPI (Fortelyzin Population Investigation) registry.

Between March 2021 and October 2024 AIS patients treated with Fortelyzin were enrolled in prospective, open, monitored, observational FORPI registry. Demographics, risk factors, baseline stroke severity, defined by National Institutes of Health Stroke Scale (NIHSS), and onset to treatment time were recorded. Safety outcomes included symptomatic intracerebral haemorrhage (ICH) (according to the ECASS III and SITS-MOST criteria) within 36 h and all-cause mortality on day 90. Efficacy outcome was evaluated as a functional independence defined by modified Rankin scale (mRS score of 0-2) on day 90.

A total of 17 636 AIS patients were treated with Fortelyzin in 329 centres participated in the FORPI registry during the study period (median age 68 [60; 75]; 44% women; median baseline NIHSS score: 11 [8;16] points; median onset to treatment time: 2.4 [1.8; 3.1] h. 73% of patients (12947/17 636) received thrombolytic therapy in the first three hours from symptoms onset. The rate of symptomatic ICH according to the ECASS III criteria was 2% [1.8; 2.2] (356/17636), to the SITS-MOST criteria - 2% [1.8; 2.1] (330/17 636). All-cause mortality on day 90 was 9% [8.6; 9.4] (1588/17 636). The number of patients with mRS 0-2 score on day 90 was 61% [60.5; 61.9] (10799/17636). All safety and efficacy outcomes were comparable with FRIDA randomised clinical trial results.

The presented data confirm that intravenous thrombolysis with Fortelyzin is safe and effective in routine clinical practice when used within 4.5 h of AIS symptoms onset. These findings should encourage the wider usage of thrombolytic therapy for suitable patients.