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

Sichuan University

Status and phase: Not yet enrolling; Phase 3

Conditions: STEMI

Treatments: Drug: Enalapril; Drug: Valsartan; Drug: Sacubitril-Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT04912167

WestChinaH-CVD-003

Details and patient eligibility

About

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.

Enrollment: 376 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

376 participants in 2 patient groups

ARNI-Sacubitril-Valsartan

Experimental group

Description:

patients randomized to angiotensin receptor neprilysin inhibitor (ARNI) group will receive 2 doses of angiotensin receptor blocker (ARB) to ensure a minimum 36-hour washout period prior to initiation of ARNI therapy, and then be started with the first dose or sacubitril-valsartan.

Treatment:

Drug: Valsartan

Drug: Sacubitril-Valsartan

ACEI-Enalapril

Active Comparator group

Description:

patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril

Treatment:

Drug: Enalapril