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 (AMI)
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 (AMI)
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.
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, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.
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:
At least one of the following 8 risk factors:
Hemodynamically stable defined as:
Key Exclusion Criteria:
Caba, Buenos Aires C1280AEB, Argentina
Chemside, Queensland 4032, Australia
Xicheng, Beijing Municipality 100044, China
Shengyang, Liaoning 110016, China
Xian, Shanxi 710061, China
Plzen-Bory, 305 99, Czechia
Kaupio, 70210, Finland
Koeln-Nippes, 50733, Germany
Lower Galilee, Israel 15208, Israel
Sefad, 13100, Israel
Culiacan Sinaloa, Mexico City 80230, Mexico
N.Novgorod, 603005, Russia
S.-Petersburg, 192242, Russia
Sochy, 354057, Russia
Goethenburg, 413 45, Sweden
Meselik, Eskişehir 26480, Turkey (Türkiye)
Ankara-Cankaya, 06100, Turkey (Türkiye)
Kucukcekmece Istanbul, 34303, Turkey (Türkiye)