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NCT04509674 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,522
- Enrollment target
NCT04509674: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT04509674 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 6,522 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (745% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04509674, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,522 participants
- Enrollment target
Study 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.
Primary Outcome
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 abbre
Interventions
- DRUG Placebo
- DRUG Empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,522 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2023-11-05 |
| Phase | Phase 3 |
What the finished NCT04509674 record still lists
NCT04509674 is an interventional study that assigns participants to a tested intervention. Its 6,522 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (745% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04509674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04509674 about?
NCT04509674 is a clinical study titled "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)". 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 disea...
What is the current status of trial NCT04509674?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,522 participants. The study started on 2020-12-16. Estimated completion is 2023-11-05.
What interventions are being tested in trial NCT04509674?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT04509674?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04509674's enrollment target sits among peer trials
6,522 35th of 2000 higher than 1,966 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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