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)

Conditions

• Myocardial Infarction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  Empagliflozin
• Placebo — DRUG
  Placebo

Study Details

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.

Key Dates

Start date

Dec 16, 2020

Status verified

Dec 2024

Primary completion

Nov 5, 2023

Completion

Nov 5, 2023

Study Design

Enrollment

6,522 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin 10 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Composite of Time to First Heart Failure Hospitalisation or All-cause Mortality [ Time Frame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days. ]

Locations (85)

Find similar trials in Alexander City, AL

Related Studies

• Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
• Heart Attack Research Program: Platelet Sub-Study (HARP)
  Recruiting · NYU Langone Health · New York, New York
• Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
  Recruiting · Mayo Clinic · Rochester, Minnesota
• Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
  Recruiting · Centre hospitalier de l'Université de Montréal (CHUM) · Winston-Salem, North Carolina