CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,522 enrolled
Drug / intervention
Empagliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04509674
NCT04509674Phase 3Completed

EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction

Boehringer Ingelheim·interventional·Posted Aug 12, 2020·Updated Jan 7, 2025

In Brief

A Phase 3 clinical trial evaluating Empagliflozin and Placebo for Myocardial Infarction. Completed, enrolled 6,522 participants across 439 sites in 22 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Japan, Netherlands, Poland, Romania, Russia, Serbia, South Korea, Spain, Ukraine, United States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 12, 2020
Enrollment StartDec 16, 2020
Primary CompletionNov 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.9 years ago

Interventions

Empagliflozindrug

Empagliflozin

Placebodrug

Placebo