ABSTRACT NUMBER: ESOC2026A2477 METHOD OF CONSENT AND TIME TO RANDOMIZATION IN THE ESCAPE NEXT TRIAL

Abstract Background and aims In recent years, stroke trials in many jurisdictions have moved towards a system of deferred consent, in which the participant is enrolled as quickly as possible and consent is sought thereafter. We studied the use of various consent strategies in the ESCAPE Next trial, an international acute stroke trial assessing the neuroprotectant nerinetide. Methods We analyzed door-to-randomization times, method of consent (deferral, legally-authorized representative and subject), and rates of participant withdrawal across all 9 participating countries (Australia, Canada, Germany, Italy, the Netherlands, Norway, Singapore, Switzerland, the USA). Results The ESCAPE NEXT trial enrolled 850 subjects, 456 (54%) through deferred or 2 physician consent, 318 through LAR consent (37%), and 76 through subject consent (9%). The median door to randomization time was 50 minutes, which was shortest in the Netherlands (31 minutes) and longest in Singapore (62 minutes). Median door to randomization was shortest in participants enrolled by deferred or 2 physician consent (48 minutes) and longest in those enrolled by LAR consent (54 minutes), though there was significant heterogeneity based on protocol. Overall, 11 participants (1.2%) withdrew consent; though the rate was higher among participants enrolled by deferred consent (1.8%) than by LAR consent (0.63%), this was not statistically significant. Conclusions In the ESCAPE NEXT trial, the majority of participants were enrolled by deferred consent, which was associated with faster door-to-randomization times without a significant increase in the rate of participant withdrawal. These results support the benefits and acceptability of deferral of consent for acute stroke trials. Conflict of interest Nothing to disclose.