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
ClinicalTrials.gov processed this data on November 13, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified November 2023 by Boehringer Ingelheim, Eli Lilly and Company
Sponsor
Boehringer IngelheimInformation Provided by (Responsible Party)
Boehringer IngelheimClinicaltrials.gov Identifier
NCT04509674Other Study ID Numbers: 1245-0202
First Submitted: August 10, 2020
First Posted: August 12, 2020
Last Update Posted: November 14, 2023
Last Verified: November 2023
History of Changes
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Tracking Information | |
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First Submitted Date | August 10, 2020 |
First Posted Date | August 12, 2020 |
Last Update Posted Date | November 14, 2023 |
Study Start Date | December 16, 2020 |
Actual Primary Completion Date | November 5, 2023 |
Current Primary Outcome Measures(submitted: November 13, 2023) |
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Change History | Complete list of historical versions of study NCT04509674 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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Brief Title | 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) |
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 |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: RandomizedInterventional Model: Parallel AssignmentMasking: QuadruplePrimary Purpose: Treatment |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
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Intervention | Drug: Empagliflozin Empagliflozin |
Study Groups/Cohorts | Experimental: Empagliflozin Intervention:
Placebo Comparator: Placebo Intervention:
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Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
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Recruitment Status | Completed |
Actual Enrollment(submitted: November 13, 2023) | 6522 |
Actual Study Completion Date | November 5, 2023 |
Actual Primary Study Completion Date | November 5, 2023 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Sexes Eligible for Study: All |
Ages | 18 Years and Older (Adult, Older Adult) |
Accepts Healthy Volunteers | No |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Australia, Australia, Australia, Australia, Australia, Australia, Australia, Australia, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Bulgaria, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, Denmark, Denmark, Denmark, Denmark, Denmark, Denmark, France, France, France, France, France, France, France, France, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, India, India, India, India, India, India, India, India, India, India, India, India, India, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Israel, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Romania, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Russian Federation, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Serbia, Spain, Spain, Spain, Spain, Spain, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine, Ukraine |
Administrative Information | |
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NCT Number | NCT04509674 |
Other Study ID Numbers | 1245-0202 |
Has Data Monitoring Committee | Yes |
U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Not Provided |
IPD Sharing Statement | Plan to Share IPD: Yes |
Responsible Party | Boehringer Ingelheim, Boehringer Ingelheim |
Study Sponsor | Boehringer Ingelheim |
Collaborators | Eli Lilly and Company |
Investigators | Not Provided |
PRS Account | Boehringer Ingelheim |
Verification Date | November 2023 |