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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,669
LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules
Matching placebo of LCZ696 tablets
Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint
A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure
Time frame: From randomization to first occurrence (up to approximately 43 months)
Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization
A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.
Time frame: Time from randomization to first occurrence (up to approximately 43 months)
Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF
A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure
Time frame: Time from randomization to first occurrence (approximately up to 43 months)
Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke
A confirmed composite endpoint for this outcome measure includes cardiovascular death, non-fatal spontaneous myocardial infarction or non-fatal stroke
Time frame: Time from randomization to first occurrence (approximately up to 43 months)
Total Number of Confirmed Composite Endpoints
A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization
Time frame: Time from randomization to end of study (approximately up to 43 months)
All-cause Mortality for Full Analysis Set (FAS)
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Matching placebo of ramipril capsule
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
matching placebo of valsartan for one day to patients who will be randomized to received ramipril
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Huntsville, Alabama, United States
Novartis Investigative Site
Gilbert, Arizona, United States
Novartis Investigative Site
Bakersfield, California, United States
Novartis Investigative Site
Carmichael, California, United States
Novartis Investigative Site
Los Alamitos, California, United States
Novartis Investigative Site
Northridge, California, United States
Novartis Investigative Site
Orange, California, United States
Novartis Investigative Site
San Francisco, California, United States
...and 476 more locations
All-cause mortality defined as deaths related to Cardiovascular (CV) and non-CV events for patients in the Full Analysis Set up to a cut-off date of 31-Dec-2020.
Time frame: Time from randomization to death (approximately up to 43 months)