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Paradise-MI

Title
PARADISE-MI: Prospective ARNI versus ACE inhibitor trial to Determine Superiority in reducing heart failure Events after Myocardial Infarction- A multi-center, randomized, double-blind, active-controlled, parallel-group 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.
Description
The purpose of this study is to test if Entresto TM taken twice a day, compared to Ramipril taken twice a day, is safe and effective in reducing complications following a heart attack.  Entresto TM is a medicine which has been approved by the FDA for the treatment of chronic heart failure and reduced ejection fraction.  It has not been approved for treatment following a heart attack.  The other medicine in this study, also called the comparator drug, is Ramipril which is currently available on the market and approved for the treatment of patients with clinical signs of congestive heart failure after a heart attack.  We are conducting this study to find out which of these two medicines is a better treatment for patients after a heart attack who have LV dysfunction and/or pulmonary congestion.LV dysfunction” is a condition where the heart is unable to adequately pump the blood through the heart. This leads to fluid build-up, most often in the lungs. “Pulmonary congestion” is a build-up of fluid in the lungs leading to shortness of breath.
Trial Information
Principal Investigator: Dr. Harry Colfer, MD

Contact: Study Coordinator
Phone (Main): 231-487-3116

IRB Number: 2016-00067
clinicaltrials.gov: 02924727

More Information: