CTRI/2017/06/008867
Active, not recruiting
Phase 3
A multi-center, randomized, double-blind, active-controlled, parallel-groupPhase 3 study to evaluate the efficacy and safety of LCZ696 compared toramipril on morbidity and mortality in high risk patients following an acutemyocardial infarction - PARADISE-MI
ovartis Healthcare Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Acute Myocardial InfarctionHealth Condition 2: I219- Acute myocardial infarction, unspecified
- Sponsor
- ovartis Healthcare Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be obtained before any assessment is performed.
- •Male or female patients greater than equal to 18 years of age.
- •At least one of the following 8 risk factors:
- •Age greater than equal to 70 years
- •eGFR less than 60 mL per min per1\.73 m2 based on MDRD formula at screening visit
- •Type I or II diabetes mellitus
- •Documented history of prior MI supported by ECG changes and or elevation of
- •cardiac enzymes consistent with MI diagnosis.
- •Atrial fibrillation as noted by ECG, associated with index MI
- •LVEF less than 30percent associated with index 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
Outcomes
Primary Outcomes
Not specified
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