A study to evaluate the effect of empagliflozin on the risk of heart failure/mortality in patients with acute myocardial infarction

JRCT ID: jRCT2071210095

Registered date:19/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Myocardial Infarction
• Date of first enrollment: 22/09/2021
• Target sample size: 260
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Israel,Japan,Republic of Korea,Japan,Netherlands,Japan,Poland,Japan,Romania,Japan,Russian Federation,Japan,Serbia,Japan,Spain,Japan,Ukraine,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): Empagliflozin (BI 10773) 10 mg or placebo corresponding to empagliflozin 10 mg is orally administered once daily.

Outcome(s)

• Primary Outcome: Composite of time to first HHF(Hospitalisation for heart failure) or all-cause mortality

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
2. Diagnosis of spontaneous AMI: STEMI or NSTEMI with randomisation to occur no later than 14 calendar days after hospital admission.
Spontaneous AMI is defined as MI with a primary etiology of an acute coronary artery disease pathology (e.g., plaque rupture/erosion, in-stent restenosis, stent thrombosis) rather than MI caused by supply-demand mismatch (e.g., sepsis, arrhythmia, anemia, or other condition).
Under these conditions, the following criteria have to be met for the diagnosis of spontaneous AMI:
Detection of rise and/or fall of cardiac enzymes (cardiac troponin, cTn or the MB fraction of creatinine kinase, CKMB) with at least one value above the 99th percentile of the upper reference limit (URL) or the local laboratory MI diagnosis cut-off value, together with evidence of myocardial ischemia with at least one of the following:
- Ischemic discomfort or other ischemia symptom(s)
- Electrocardiogram (ECG) characteristics of STEMI or NSTEMI including new or presumably new significant ST-segment-T wave (ST-T) changes
- Newly developed pathological Q waves or left bundle branch block (LBBB) in the ECG
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiologyIdentification of a coronary thrombus by angiography.
3. High risk of heart failure, defined as EITHER
a) 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 hospitalisation.
OR
b) Newly developed LVEF < 45% as measured by echocardiography, etc, during index hospitalisation.
4. In addition at least one of the following risk factors:
- Age >= 65 years
- Newly developed LVEF < 35%
- Prior myocardial infarction
- eGFR < 60 ml/min/1.73m2
- Atrial fibrillation
- Type 2 diabetes mellitus
- NTproBNP >=1,400 pg/mL for patients in sinus rhythm, >=2,800 pg/mL if atrial fibrillation; BNP >=350 pg/mL for patients in sinus rhythm, >=700 pg/mL if atrial fibrillation
- Uric acid >=7.5 mg/dL (>=446 micro-mol/L)
- Pulmonary Artery Systolic Pressure [or right ventricular systolic pressure] >=40 mmHg
- Patient not revascularized (and no planned revascularization) for the myocardial infarction
- 3-vessel coronary artery disease at time of the myocardial infarction
- Diagnosis of peripheral artery disease

Exclude criteria

1. Diagnosis of chronic heart failure prior to the myocardial infarction
2. Systolic blood pressure <= 90 mmHg at randomisation
3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation
4. Coronary Artery Bypass Grafting planned at time of randomisation
5. Current diagnosis of Takotsubo cardiomyopathy
6. Any current severe (stenotic or regurgitant) valvular heart disease
7. eGFR < 20 ml/min/1.73m2 or on dialysis
8. Type I diabetes mellitus
9. History of ketoacidosis

Related Information

• Primary Sponsor: Crisan Ioan
• Secondary ID(s): NCT04509674