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)
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|ClinicalTrials.gov Identifier: NCT04509674|
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : July 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Empagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Blinded investigator review of events in place of centralized adjudication.|
|Official Title:||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|
|Actual Study Start Date :||December 16, 2020|
|Estimated Primary Completion Date :||December 20, 2022|
|Estimated Study Completion Date :||December 20, 2022|
|Placebo Comparator: Placebo||
- Composite of time to first heart failure hospitalisation or all-cause mortality [ Time Frame: up to 24 months ]
- Total number of HHF or all-cause mortality [ Time Frame: up to 24 months ]
- Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality [ Time Frame: up to 24 months ]
- Total number of non-elective all-cause hospitalisations or all-cause mortality [ Time Frame: up to 24 months ]
- Total number of hospitalisations for MI or all-cause mortality [ Time Frame: up to 24 months ]
- Time to CV mortality [ Time Frame: up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509674
|Contact: Boehringer Ingelheimemail@example.com|