LETTER: An update on changes to the design of the ODIN trial

We recently published, in EuroIntervention Volume 20, Number 5, the rationale and design of the One-Month DAPT in CABG Patients (ODIN) trial (ClinicalTrials.gov: NCT05997693)1. ODIN is designed to address a critical gap in knowledge: whether short-term dual antiplatelet therapy (DAPT) with low-dose aspirin and ticagrelor is more effective than aspirin alone to reduce the risk of ischemic events and graft failure after coronary artery bypass graft (CABG) surgery in patients with chronic coronary syndromes while minimising the risk of bleeding associated with longer DAPT durations. The trial was initially conceived as a prospective, randomised, double-blind, placebo-controlled, international, multicentre study.

Despite our best efforts over the past year, we have encountered significant challenges in securing a suitable placebo for ticagrelor. These challenges have been multifaceted and have included difficulties identifying a manufacturer, the prohibitive cost associated with placebo production, and the lengthy time frames required for manufacturing and regulatory approval. Ultimately, these obstacles have made it unfeasible to conduct the study as a placebo-controlled trial as initially planned. This experience is not unique to ODIN; the challenges faced by investigator-initiated drug...