EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)
CompletedPhase 3Results postedLast updated 7 January 2025
What this trial tests
Phase 3 trial testing Empagliflozin in Myocardial Infarction in 6,522 participants. Completed in 5 November 2023.
18 and older, any sex, with Myocardial Infarction. 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.
Composite of Time to First Heart Failure Hospitalisation or All-cause MortalityPrimary· From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
The composite of time to first heart failure hospitalization or all-cause mortality is reported as the incidence rate of the first occurrence of hospitalization for heart failure (HHF) or death, whichever is earliest.
The incidence rate was calculated as: the number of patients with an event for hospitalization for heart failure or death by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).
Group
Value
95% CI
Placebo
6.58
5.86 – 7.35
Empagliflozin 10 mg
5.85
5.17 – 6.57
Key Secondary Endpoint - Total Number of Hospitalisations for Heart Failure (HHF) or All-cause MortalitySecondary· From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
The total number of hospitalisations for heart failure (HHF) or all-cause mortality is reported using the adjusted event rate.
The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an of
Group
Value
95% CI
Placebo
8.25
6.92 – 9.83
Empagliflozin 10 mg
7.14
5.91 – 8.63
Key Secondary Endpoint - Total Number of Non-elective Cardiovascular (CV) Hospitalisations or All-cause MortalitySecondary· From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
The total number of non-elective cardiovascular (CV) hospitalisations or all-cause mortality is reported using the adjusted event rate.
The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used
Group
Value
95% CI
Placebo
16.90
15.10 – 18.92
Empagliflozin 10 mg
15.52
13.82 – 17.43
Key Secondary Endpoint - Total Number of Non-elective All-cause Hospitalisations or All-cause MortalitySecondary· From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
The total number of non-elective all-cause hospitalisations or all-cause mortality is reported using the adjusted event rate.
The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an off
Group
Value
95% CI
Placebo
26.28
23.92 – 28.87
Empagliflozin 10 mg
22.96
20.84 – 25.31
Key Secondary Endpoint - Total Number of Hospitalisations for Myocardial Infarction (MI) or All-cause MortalitySecondary· From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
The total number of hospitalisations for myocardial infarction (MI) or all-cause mortality is reported using the adjusted event rate.
The adjusted event rate is based on a negative binomial model adjusted for factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time
Group
Value
95% CI
Placebo
6.27
5.19 – 7.58
Empagliflozin 10 mg
6.66
5.49 – 8.08
Time to Cardiovascular (CV) MortalitySecondary· From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
The time to cardiovascular (CV) mortality is reported as the incidence rate of cardiovascular (CV) mortality, including deaths of unknown cause.
The incidence rate was calculated as: the number of patients with a cardiovascular death event by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).
Group
Value
95% CI
Placebo
2.76
2.31 – 3.25
Empagliflozin 10 mg
2.78
2.33 – 3.28
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease.
People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes.
Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD
· Phase 2
· not yet recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients
· Phase 4
· recruiting
NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease
· Phase 3
· recruiting
NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
· Phase 2, PHASE3
· active not recruiting
NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
· Phase 4
· not yet recruiting
Other recruiting trials for Myocardial Infarction
Currently open trials in the same condition.
NCT07257198 — Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone
· Phase 3
· recruiting
NCT07402642 — Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome
· NA
· recruiting
NCT07301034 — A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo,
· Phase 3
· recruiting
NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
· recruiting
NCT07138911 — Effect of Home-based Exercise Plan Mediated by Use of Digital Health App on Kinesiophobia and Functional Capacity
· NA
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 7 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04509674.