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
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
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.
Inclusion Criteria:
Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
High risk of HF, defined as EITHER
Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization.
OR
Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
In addition at least one of the following risk factors:
Exclusion Criteria:
Torrance, California 90502, United States
Washington D.C., District of Columbia 20037, United States
Oklahoma City, Oklahoma 73120, United States
Ciudad Autonoma Buenos Aires, C1180 AAX, Argentina
Aracaju - SE, 49055-530, Brazil
Haerbin, 150001, China
Bad Friedrichshall, 74177, Germany
Bremen, 28277, Germany
Freiburg I. Breisgau, 79106, Germany
Beer Yaacov, 70300, Israel
Aichi, Kasugai, 486-8510, Japan
Aichi, Toyota, 471-8513, Japan
Chiba, Matsudo, 270-2251, Japan
Chiba, Matsudo, 271-0077, Japan
Fukuoka, Fukuoka, 810-0001, Japan
Gifu, Gifu, 500-8717, Japan
Gifu, Ogaki, 503-8502, Japan
Hiroshima, Hiroshima, 734-8530, Japan
Hyogo, Himeji, 670-0981, Japan
Ibaraki, Kasama, 309-1793, Japan
Ibaraki, Tsuchiura, 300-0028, Japan
Ishikawa, Kanazawa, 920-8530, Japan
Kanagawa, Isehara, 259-1193, Japan
Kanagawa, Sagamihara, 252-5188, Japan
Kanagawa, Yokohama, 232-0024, Japan
Kumamoto, Kumamoto, 861-4193, Japan
Kumamoto, Kumamoto, 861-8520, Japan
Nagano, Nagano, 380-0814, Japan
Osaka, Osaka, 543-0035, Japan
Tokyo, Chuo-ku, 104-8560, Japan
Saint Petersburg, 192242, Russia
Cheongiu, 28644, South Korea
Daejoen, 35015, South Korea
Ivano-Frankivsk, 76008, Ukraine
Lviv, 79015, Ukraine
Uzhhorod, 88000, Ukraine