NCT02924727

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,669 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	LCZ696 (sacubitril/valsartan)	LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
DRUG	Ramipril	Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules
DRUG	Placebo of LCZ696	Matching placebo of LCZ696 tablets
DRUG	Placebo of ramipril	Matching placebo of ramipril capsule
DRUG	Valsartan	Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day to patients who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization
DRUG	Placebo of valsartan	matching placebo of valsartan for one day to patients who will be randomized to received ramipril

Timeline

• Start date: 2016-12-09
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2016-10-05
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

486 sites across 41 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study