Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events… (NCT02924727) | Clinical Trial Compass
CompletedPhase 3
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
United States5,669 participantsStarted 2016-12-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
Exclusion criteria
✕. Known history of chronic HF prior to randomization
✕. Cardiogenic shock within the last 24 hours prior to randomization
✕. Persistent clinical HF at the time of randomization
✕. Coronary artery bypass graft (CABG) performed or planned for index MI
✕. Clinically significant right ventricular MI as index MI
✕. Symptomatic hypotension at screening or randomization
✕. Patients with a known history of angioedema
What they're measuring
1
Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint
Timeframe: From randomization to first occurrence (up to approximately 43 months)