EUCTR2016-002154-20-DE
Active, not recruiting
Phase 1
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 - PARADISE-MI
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- eft ventricular dysfunction following an acute myocardial infarction.
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 5661
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients \= 18 years of age.
- •2\. Diagnosis of spontaneous AMI based on the universal MI definition with randomization to occur between 12 hours and 7 days after index event presentation.
- •3\. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:
- •LVEF \=40% after index MI presentation and prior to randomization and/or
- •Pulmonary congestion requiring intravenous treatment during the index hospitalization
- •4\. At least one of the following 8 risk factors:
- •Age \= 70 years
- •eGFR \<60 mL/min/1\.73 m2 based on MDRD formula at screening visit
- •Type I or II diabetes mellitus
- •Documented history of prior MI
Exclusion Criteria
- •1\. Known history of chronic HF prior to randomization
- •2\. Cardiogenic shock within the last 24 hours prior to randomization
- •3\. Persistent clinical HF at the time of randomization
- •4\. Coronary artery bypass graft (CABG) performed or planned for index MI
- •5\. Clinically significant right ventricular MI as index MI
- •6\. Symptomatic hypotension at screening or randomization
- •7\. Patients with a known history of angioedema
- •8\. Stroke or transient ischemic attack within one month prior to randomization
- •9\. Known or suspected bilateral renal artery stenosis
- •10\. Clinically significant obstructive cardiomyopathy
Outcomes
Primary Outcomes
Not specified
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