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NCT04564742: DAPA-MI

Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.

Completed Phase 3 Results posted Last updated 7 March 2025
What this trial tests

Phase 3 trial testing Dapagliflozin in Acute Myocardial Infarction in 4,017 participants. Completed in 5 July 2023.

Timeline
22 December 2020
Primary endpoint
5 July 2023
5 July 2023

Quick facts

Lead sponsorAstraZeneca
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment4,017
Start date22 December 2020
Primary completion5 July 2023
Estimated completion5 July 2023
Sites103 locations across Sweden, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Acute Myocardial Infarction or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set) Primary · 29 months

Study participants received dapagliflozin 10 mg or matching placebo, given once daily in addition to SoC. Overall, the mean study duration was 12.0 months (time in study until last visit) with an accumulated 4023.9 participant-years. The maximum study duration for any participant was 29 months. "Number of Events" for NYHA corresponds to the number of participants with a non-missing value for NYHA functional class at the last visit, and that all participants with a non-missing value take part in the analysis comparing their NYHA class value with all other participants with a NYHA value, accord

The hierachical composite endpoint of all components
GroupValue95% CI
Dapa 10 mg1990
Placebo1970
Death, adjudicated
GroupValue95% CI
Dapa 10 mg41
Placebo33
Hospitalisation due to HF
GroupValue95% CI
Dapa 10 mg32
Placebo41
Non-fatal MI
GroupValue95% CI
Dapa 10 mg29
Placebo32
AF/Flutter event
GroupValue95% CI
Dapa 10 mg8
Placebo15
New onset of T2DM
GroupValue95% CI
Dapa 10 mg40
Placebo74
NYHA Classification at last visit, measuring limitations of physical activity
GroupValue95% CI
Dapa 10 mg1839
Placebo1773
Body Weight decrease of at least 5% at last visit
GroupValue95% CI
Dapa 10 mg684
Placebo468

Adverse events — posted to ClinicalTrials.gov

Time frame: Time frame was from date of randomization and up to and including last day in study, up to 29 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dapa 10 mg
Serious: 449/2019 (22%)
Deaths: 41/2019
Placebo
Serious: 404/1998 (20%)
Deaths: 33/1998

Serious adverse events (353 terms)

ReactionSystemDapa 10 mgPlacebo
Cardiac failureCardiac disorders
Non-cardiac chest painGeneral disorders
Acute myocardial infarctionCardiac disorders
Angina pectorisCardiac disorders
Chest painGeneral disorders
PneumoniaInfections and infestations
Angina unstableCardiac disorders
Atrial fibrillationCardiac disorders
Acute kidney injuryRenal and urinary disorders
SyncopeNervous system disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
PericarditisCardiac disorders
Lower respiratory tract infectionInfections and infestations
Ischaemic strokeNervous system disorders
Dressler's syndromeCardiac disorders
CholecystitisHepatobiliary disorders
Urinary tract infectionInfections and infestations
Cardiac arrestCardiac disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Musculoskeletal painMusculoskeletal and connective tissue disorders
BradycardiaCardiac disorders
HaematuriaRenal and urinary disorders
Cardiac ventricular thrombosisCardiac disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
HypotensionVascular disorders

Most-reported serious reactions: Cardiac failure, Non-cardiac chest pain, Acute myocardial infarction, Angina pectoris, Chest pain, Pneumonia, Angina unstable, Atrial fibrillation.

Data from ClinicalTrials.gov NCT04564742 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation and atherosclerosis: signaling pathways and therapeutic intervention.
    Kong P, Cui ZY, Huang XF, Zhang DD, et al · · 2022 · cited 749× · PMID 35459215 · DOI 10.1038/s41392-022-00955-7
  2. Left ventricular remodelling post-myocardial infarction: pathophysiology, imaging, and novel therapies.
    Frantz S, Hundertmark MJ, Schulz-Menger J, Bengel FM, et al · · 2022 · cited 401× · PMID 35511857 · DOI 10.1093/eurheartj/ehac223
  3. Empagliflozin in acute myocardial infarction: the EMMY trial.
    von Lewinski D, Kolesnik E, Tripolt NJ, Pferschy PN, et al · · 2022 · cited 213× · PMID 36036746 · DOI 10.1093/eurheartj/ehac494
  4. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure.
    James S, Erlinge D, Storey RF, McGuire DK, et al · · 2024 · cited 180× · PMID 38320489 · DOI 10.1056/evidoa2300286
  5. Anti-inflammatory role of SGLT2 inhibitors as part of their anti-atherosclerotic activity: Data from basic science and clinical trials.
    Scisciola L, Cataldo V, Taktaz F, Fontanella RA, et al · · 2022 · cited 91× · PMID 36148061 · DOI 10.3389/fcvm.2022.1008922
  6. Sodium-Glucose Cotransporter-2 Inhibitors After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Population-Based Investigation.
    Kwon O, Myong JP, Lee Y, Choi YJ, et al · · 2023 · cited 44× · PMID 37421263 · DOI 10.1161/jaha.122.027824
  7. Prevalence and prognostic impact of left ventricular systolic dysfunction or pulmonary congestion after acute myocardial infarction.
    Hamilton E, Desta L, Lundberg A, Alfredsson J, et al · · 2023 · cited 25× · PMID 36732932 · DOI 10.1002/ehf2.14301
  8. Impact of the SGLT2-inhibitor empagliflozin on inflammatory biomarkers after acute myocardial infarction - a post-hoc analysis of the EMMY trial.
    Benedikt M, Mangge H, Aziz F, Curcic P, et al · · 2023 · cited 24× · PMID 37407956 · DOI 10.1186/s12933-023-01904-6

Verify or expand the search:

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Other AstraZeneca trials

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