Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction
Study context
- Population
- Post-MI patients within 72 hours of index percutaneous coronary intervention (PCI)recruitment completed
- Participants
- 7,062 patients
- Planned comparison
- Colchicine vs placebo and spironolactone vs placebo
- Primary endpoint
- Colchicine: first CV death, recurrent myocardial infarction (MI), stroke or unplanned ischaemia-driven revascularization. Spironolactone (coprimary): (1) total CV death or new/worsening HF; (2) first CV death, new/worsening HF, recurrent MI or stroke
Methodological details2 × 2 factorial, blinded participants, providers, research personnel and outcome adjudicators, 104 centres in 14 countries, Recruitment finished November 8, 2022; results planned for fall 2024
- 2 × 2 factorial
- Blinded participants, providers, research personnel and outcome adjudicators
- 104 centres in 14 countries
- Recruitment finished November 8, 2022; results planned for fall 2024
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction. Am Heart J. Published 25 June 2024. doi:10.
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