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 Save

Date Added
August 25th, 2017
PRO Number
Pro00065663
Researcher
Kurt Barringhaus
Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The purpose of this study is to test if LCZ696 taken twice a day, compared to ramipril taken twice a day, is safe and effective in reducing complications following an acute myocardial infarction (post-AMI), such as death from cardiovascular (CV) causes, hospitalization for heart failure (HF), or outpatient HF.

LCZ696 is a medicine which has been approved by the US Food and Drug Administration (FDA) for the treatment of people with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It has not been approved for treatment following a heart attack, the medical condition that you have. The medicine being tested in this study is not currently available for patients with your medical condition to receive a prescription for and/or to buy in any country. To date, over 21,000 subjects have taken LCZ696 in studies that have been performed in healthy subjects and patients with hypertension, heart failure with reduced ejection fraction, and heart failure with preserved ejection fraction.

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 post-AMI. Ramipril belongs to a class of medications called angiotensin-converting enzyme inhibitors, or ACE inhibitors (ACEIs), recommended as standard -of- care to treat the post-AMI patients.

Institution
Palmetto
Recruitment Contact
Kurt Barringhaus
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

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