drugset / Trial / NCT04564742
Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the effect of dapagliflozin versus placebo, given once daily in addition to Standard of Care (SoC) therapies for patients with myocardial infarction (MI), for hospitalisation for heart failure (HHF), cardiovascular (CV) death, and other cardiometabolic outcomes.
Timeline
- Start
- 2020-12-22
- Primary completion
- 2023-07-05
- Completion
- 2023-07-05
Outcome
Met primary endpoint
registry analysis (superiority test); Dapa 10 mg vs Placebo; p <0.001; Win Ratio (WR) 1.34 (95% CI 1.20 to 1.50) NCT04564742 ↗
paper The analysis of the primary hierarchical composite outcome resulted in significantly more wins for dapagliflozin than for placebo PMID 38320489 ↗
Publications
- James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Eriksson N, Andersen K, Austin D, Arefalk G, Carrick D, Hofmann R, Hoole SP, Jones DA, Lee K, Tygesen H, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024 Feb;3(2):EVIDoa2300286. doi: 10.1056/EVIDoa2300286. Epub 2023 Nov 11.
- James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Bjorkgren I, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Rationale and design of the DAPA-MI trial: Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction. Am Heart J. 2023 Dec;266:188-197. doi: 10.1016/j.ahj.2023.08.008. Epub 2023 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |