Rationale and design of the DAPA-MI trial: Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction
Study context
- Population
- Patients without known DM or established heart failure (HF), presenting with myocardial infarction (MI) and impaired LV systolic function or Q-wave MI
- Planned comparison
- Dapagliflozin 10 mg once daily vs placebo, in addition to standard of care
- Primary endpoint
- Hierarchical composite (win-ratio) of death, hospitalization for HF (HHF), nonfatal MI, AF/flutter, new-onset T2DM, NYHA class at last visit, and body weight decrease ≥5% at last visit
Methodological detailsrationale and design, multicentre, parallel-group, registry-based, double-blind, placebo-controlled, phase 3, Planned 4,000 patients for 80% power assuming true win-ratio 1.20, Registry-based framework using national clinical registries (Sweden and UK) for recruitment, randomisation, blinding and data collection
- Rationale and design
- Multicentre
- Parallel-group
- Registry-based
- Double-blind
- Placebo-controlled
- Phase 3
- Planned 4,000 patients for 80% power assuming true win-ratio 1.20
- Registry-based framework using national clinical registries (Sweden and UK) for recruitment, randomisation, blinding and data collection
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of the DAPA-MI trial: Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction. Am Heart J. Published 28 August 2023. doi:10.
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