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Active Clinical Trials

PARADISE-MI

Active NCT:
02924727
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Novartis Pharmaceuticals
Contact: 

For more information, please contact Ken Rayl at 412-359-6860 or Kenneth.Rayl@ahn.org

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

Purpose: 

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  1. 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
  • Atrial fibrillation as noted by ECG, associated with index MI
  • LVEF <30% associated with index MI
  • Worst Killip class III or IV associated with index MI requiring intravenous treatment
  • STEMI without reperfusion therapy within the first 24 hours after presentation
  1. Hemodynamically stable defined as:
  • SBP ≥ 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization
  • SBP ≥ 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization
  • No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization

Key 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
  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 at screening
  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 varices
  15. Previous use of LCZ696 or EntrestoTM
  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