The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction

Last updated: September 23, 2021
Sponsor: West China Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Coronary Artery Disease

Congestive Heart Failure

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT04912167
WestChinaH-CVD-003
  • Ages 18-75
  • All Genders

Study Summary

The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with ST-elevation myocardial infarction (STEMI) than enalapril.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged between 18 - 75 years old
  • First-time ST-segment elevation myocardial infarction based on the newest ESCguidelines
  • Timely primary percutaneous coronary intervention within 12 hours from onset
  • Written informed consent acquired

Exclusion

Exclusion Criteria:

  • Known history of or persistent clinical chronic heart failure prior to randomization
  • Previous use of ARNI, or intolerance or contraindications to study drugs includingARNI or ACEI
  • History of significant chronic coronary obstruction and adverse ventricular remodeling
  • History of any cardiomyopathy, valvular heart disease, congenital heart disease, stentor CABG, or planned open-heart surgery within 3 months
  • History of hepatic impairment or history of cirrhosis with evidence of portalhypertension
  • History of chronic renal dysfunction, or eGFR < 30 ml/min/1.73 m2
  • History of malignancy and with a life span less than one year
  • Patients with a known history of angioedema related to previous ACEIs/ARB therapy.
  • With contraindication to MRI examination (pacemaker and claustrophobia) or cannotfinish breath-holding when lying on the examination bed
  • Pregnancy or nursing women

Study Design

Total Participants: 376
Study Start date:
November 01, 2021
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • West China Hospital

    Chengdu, Sichuan 621000
    China

    Site Not Available

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