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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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, 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..

Official Title

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 AMI

Keywords

Acute Myocardial Infarction Spontaneous AMI HF hospitalization outpatient HF LV systolic dysfunction pulmonary congestion STEMI NSTEMI randomized clinical trial LCZ696 ramipril Infarction Myocardial Infarction Valsartan LCZ 696 Angiotensin-Converting Enzyme Inhibitors

Eligibility

You can join if…

Open to people ages 18 years and up

  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. (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)

  3. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:
  4. LVEF ≤40% after index MI presentation and prior to randomization and/or
  5. Pulmonary congestion requiring intravenous treatment with diuretics,vasodilators, vasopressors and/or inotropes, during the index hospitalization
  6. At least one of the following 8 risk factors:
  7. Age ≥ 70 years
  8. eGFR <60 mL/min/1.73 m2 based on MDRD formula at screening visit

  9. Type I or II diabetes mellitus
  10. Documented history of prior MI
  11. Atrial fibrillation as noted by ECG, associated with index MI
  12. LVEF <30% associated with index MI
  13. Worst Killip class III or IV associated with index MI requiring intravenous treatment
  14. STEMI without reperfusion therapy within the first 24 hours after presentation
  15. Hemodynamically stable defined as:
  16. SBP ≥ 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization
  17. SBP ≥ 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization
  18. No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization

Key

You CAN'T join if...

  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
  11. . Open-heart surgery performed within one month prior to randomization or planned cardiac surgery w/in the 3 months prior to randomization
  12. . eGFR < 30 ml/min/1.73 m2 as measured by MDRD at screening

  13. . Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at randomization
  14. . Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
  15. . Previous use of LCZ696
  16. . History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1year.
  17. . History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
  18. . Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco, California, 94143, United States
  • Novartis Investigative Site accepting new patients
    Santa Rosa, California, 95405, United States
  • Novartis Investigative Site accepting new patients
    Carmichael, California, 95608, United States
  • Novartis Investigative Site accepting new patients
    Bakersfield, California, 93301, United States
  • Novartis Investigative Site accepting new patients
    Sylmar, California, 91342, United States
  • Novartis Investigative Site accepting new patients
    Northridge, California, 91325, United States
  • Novartis Investigative Site withdrawn
    Beverly Hills, California, 90211, United States
  • Novartis Investigative Site accepting new patients
    Huntington Beach, California, 92648, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02924727
Phase
Phase 3
Study Type
Interventional
Last Updated
November 14, 2017
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