Prospective ARNI versus ACE inhibitor trial to Determine Superiority in reducing heart failure Events after Myocardial Infarctio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5650

Inclusion Criteria

1. Male or female patients = 18 years of age.
2. Diagnosis of spontaneous AMI based on the universal MI definition with randomization to occur between 12 hours and 7 days after index event presentation.
3. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:
• LVEF =40% after index MI presentation and prior to randomization and/or
• Pulmonary congestion requiring intravenous treatment during the index hospitalization
4. At least one of the following 8 risk factors:
• Age = 70 years
• eGFR <60 mL/min/1.73 m2 based on MDRD formula at screening visit
• Type I or II diabetes mellitus
• Documented history of prior MI
• Atrial fibrillation as noted by ECG, associated with index MI
• LVEF <30% associated with index MI
• Worst Killip class III or IV associated with index MI requiring intravenous treatment
• STEMI without reperfusion therapy within the first 24 hours after presentation
5. Hemodynamically stable defined as:
• SBP = 100 mmHg at randomization for patients who received
ACEi/ARB during the last 24 hours prior to randomization
• SBP = 110 mmHg at randomization for patients who did not receive
ACEi/ARB during the last 24 hours prior to randomization
• No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2797
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2853

Exclusion Criteria

2. Cardiogenic shock within the last 24 hours prior to randomization
3. Persistent clinical HF at the time of randomization
4. Coronary artery bypass graft (CABG) performed or planned for index MI
5. Clinically significant right ventricular MI as index MI
6. Symptomatic hypotension at screening or randomization
7. Patients with a known history of angioedema
8. Stroke or transient ischemic attack within one month prior to randomization
9. Known or suspected bilateral renal artery stenosis
10. Clinically significant obstructive cardiomyopathy
11. Open-heart surgery performed within one month prior to rand or planned cardiac surgery w/in the 3 months prior to rand
12. eGFR < 30 ml/min/1.73 m2 as measured by MDRD at screening
13. Serum potassium > 5.2 mmol /L at (or equivalent plasma potassium value) randomization
14. Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
15. Previous use of LCZ696 or Entresto
16. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1year.
17. History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
18. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 4/12/2021

Prospective ARNI versus ACE inhibitor trial to Determine Superiority in reducing heart failure Events after Myocardial Infarctio

Recruitment & Eligibility

Study & Design

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