Phase 3
Completed N=5,669
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
Source: ClinicalTrials.gov NCT02924727 ↗Enrolled (actual)
5,669
Serious AEs
40.3%
Results posted
Jun 2023
Primary outcomePrimary: Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint — 338; 373; 168; 191 Count of Participants — p=0.1659
◆ Published Evidence
Emerging
16citations · ~8 / year
Angiotensin Receptor-Neprilysin Inhibition in Patients With STEMI vs NSTEMI.
Summary
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.
Linked Publications (5)
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Angiotensin Receptor-Neprilysin Inhibition in Patients With STEMI vs NSTEMI.
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Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE-MI.
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Rates of Sudden Death After Myocardial Infarction-Insights From the VALIANT and PARADISE-MI Trials.
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Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists: Insight from the PARADISE MI trial.
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Pulmonary Congestion and Left Ventricular Dysfunction After Myocardial Infarction: Insights From the PARADISE-MI Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint |
338; 373; 168; 191; 170; 195 | 0.1659 |
| SECONDARY Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization |
308; 335 | 0.2507 |
| SECONDARY Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF |
201; 237 | 0.0732 |
| SECONDARY Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke |
315; 349 | 0.1785 |
| SECONDARY Total Number of Confirmed Composite Endpoints |
416; 455 | 0.0452 sig |
| SECONDARY All-cause Mortality for Full Analysis Set (FAS) |
213; 242 | 0.1556 |
Eligibility Criteria
Inclusion Criteria
- 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 5.2 mmol /L (or equivalent plasma potassium value) at randomization
- 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
- Previous use of LCZ696
- 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.
- 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
- Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
Data sourced from ClinicalTrials.gov (NCT02924727) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.