PARADISE-MI: Prospective ARNI versus ACE inhibitor trial to DetermIne
Completed · 2017 until 2021
Maeder Micha, Gemperle Michaela
A multi-center, randomized, double-blind, active-controlled, parallelgroup Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk
patients following an acute myocardial infarction
The purpose of this study is to evaluate the efficacy and safety of
LCZ696 compared to ramipril, in reducing the occurrence of
cardiovascular (CV) death, heart failure (HF) hospitalization and
outpatient HF (time-to-first event analysis) in post-AMI patients with
evidence of left ventricular (LV) systolic dysfunction and/or pulmonary
congestion, without a known prior history of chronic HF.
This is an event-driven study which is a well-established study design for long-term cardiovascular outcome trials in post-acute myocardial
infarction (AMI) patients. While the composite of CV death or HF
hospitalization is a well-established mortality and morbidity endpoint, the addition of the outpatient HF component, which in this study represents the confirmed diagnosis of new onset symptomatic HF, aims to capture the clinically important outpatient event that contributes to the totality of HF morbidity following an AMI presenting as either inpatient (i.e., HF hospitalization) or outpatient (i.e., outpatient HF) events.
Ramipril is chosen as an active comparator of the study representing the guideline-recommended standard-of-care angiotensin converting Enzyme (ACE) inhibitors shown to improve survival and reduce HF morbidity in high-risk post-AMI patients