Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Myocardial Infarction

In brief

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.

Key facts

Study ID

NCT02924727

Run by

Novartis Pharmaceuticals

People needed

5669

Starts

2016-12-09

Expected to finish

2021-02-26

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years of age.
• Diagnosis of spontaneous AMI based on the universal MI definition* with randomization to occur between 12 hours and 7 days after index event presentation. (*patients with spontaneous MI event determined to be secondary to another medical condition such as anemia, hypotension, or arrhythmia OR thought to be caused by coronary vasospasm with document normal coronary arteries are not eligible; patients with clinical presentation thought to be related to Takotsubo cardiomyopathy are also not eligible)
• 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 with diuretics, vasodilators, vasopressors and/or inotropes, during the index hospitalization
• At least one of the following 8 risk factors:
• Age ≥ 70 years
• eGFR <60 mL/min/1.73 m\^2 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
• 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
• Key Exclusion Criteria:
• Known history of chronic HF prior to randomization
• Cardiogenic shock within the last 24 hours prior to randomization
• Persistent clinical HF at the time of randomization
• Coronary artery bypass graft (CABG) performed or planned for index MI
• Clinically significant right ventricular MI as index MI
• Symptomatic hypotension at screening or randomization

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Huntsville, Alabama, United States
• Novartis Investigative Site — Gilbert, Arizona, United States
• Novartis Investigative Site — Bakersfield, California, United States
• Novartis Investigative Site — Carmichael, California, United States
• Novartis Investigative Site — Los Alamitos, California, United States
• Novartis Investigative Site — Northridge, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Sylmar, California, United States
• Novartis Investigative Site — Brandon, Florida, United States
• Novartis Investigative Site — Hollywood, Florida, United States
• Novartis Investigative Site — Jacksonville Beach, Florida, United States
• Novartis Investigative Site — Ocala, Florida, United States
• Novartis Investigative Site — Cumming, Georgia, United States
• Novartis Investigative Site — Johns Creek, Georgia, United States
• Novartis Investigative Site — Thomasville, Georgia, United States
• Novartis Investigative Site — Boise, Idaho, United States
• Novartis Investigative Site — Coeur d'Alene, Idaho, United States
• Novartis Investigative Site — Muncie, Indiana, United States
• Novartis Investigative Site — Munster, Indiana, United States
• Novartis Investigative Site — Richmond, Indiana, United States
• Novartis Investigative Site — Iowa City, Iowa, United States
• Novartis Investigative Site — Alexandria, Louisiana, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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