PARADISE-MI
Trial Sponsored by:
Trial Approval: Complete
Research Profile:
Professor Marc Pfeffer
Ms Barbara Meyer
Trial: clinicaltrials.gov
Trial Summary
PARADISE-MI: Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
The purpose of this study was to evaluate the efficacy and safety of LCZ696 (sacubitril-valsartan) 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-acute myocardial infarction (AMI) treatment, in reducing the occurrence of composite endpoint of cardiovascular death, heart failure (HF) hospitalisation and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of left ventricular systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.
A multi-centre, randomised, double-blind, active-controlled, parallel-group phase 3 study, PARADISE-MI demonstrated that sacubitril-valsartan was not associated with a significantly lower incidence of death from cardiovascular causes or incident HF than Ramipril among patients with AMI.
Investigators
Sponsor
- Novartis Pharmaceuticals
Chief Investigator
- Professor Marc Pfeffer
Principal Investigator
Trial Nurse
- Ms Barbara Meyer
Patient Recruitment
Recruitment status: Completed
Outputs
PARADISE-MI: https://pubmed.ncbi.nlm.nih.gov/34758252/