Sample size calculation
ACUTE CORONARY SYNDROME, RECRUITMENT, EVENT, RECRUITMENT, MAY, EVENTS
Based on the event rate in the High-Sensitivity Troponin in the Evaluation of patients with suspected Acute Coronary Syndrome (High-STEACS) trial [On April 25, 2022, a blinded assessment of the number of events accrued in the first 1925 participants was undertaken and the DMC concluded the trial would not reach the number of primary outcome events required by the planned follow-up date of September 2024. This was a consequence of interruptions to recruitment due to COVID-19 with most participants having less than 12 months follow-up at this point. To minimise the likelihood that follow-up will need to be extended, the DMC and TSC recommended recruitment continue beyond the sample size of 2270 patients. Recruitment of up to an additional 900 participants (total 3170 participants) was completed in May 2023. This should ensure 97 primary outcome events are accrued in the standard care arm by August 2024.