Status:
NOT_YET_RECRUITING
The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
Lead Sponsor:
West China Hospital
Conditions:
STEMI
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 (STEM...
Eligibility Criteria
Inclusion
- Aged between 18 - 75 years old
- First-time ST-segment elevation myocardial infarction based on the newest ESC guidelines
- Timely primary percutaneous coronary intervention within 12 hours from onset
- Written informed consent acquired
Exclusion
- Known history of or persistent clinical chronic heart failure prior to randomization
- Previous use of ARNI, or intolerance or contraindications to study drugs including ARNI or ACEI
- History of significant chronic coronary obstruction and adverse ventricular remodeling
- History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent or CABG, or planned open-heart surgery within 3 months
- History of hepatic impairment or history of cirrhosis with evidence of portal hypertension
- 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 cannot finish breath-holding when lying on the examination bed
- Pregnancy or nursing women
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT04912167
Start Date
November 1 2021
End Date
June 1 2026
Last Update
September 29 2021
Active Locations (1)
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1
West China Hospital
Chengdu, Sichuan, China, 621000