PARADISE-MI Identifier: NCT02752737

Full Title

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 AMI

Sponsor: Novartis

Condition: Acute Myocardial Infarction

Interventional (CTIMP): Phase 3 Clinical Trial
Drug:Placebo of LCZ696
Drug:Placebo of valsartan
Drug:Placebo of ramipril
Drug:LCZ696 (sacubitril/valsartan)

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.

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