Clinical trial NCT04912167: The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
Official title: A Multi-center, Prospective Randomized Controlled Trial on the Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: STEMI
Keywords: ST-elevation myocardial infarction (STEMI)
cardiovascular magnetic resonance (CMR)
angiotensin receptor neprilysin inhibitor (ARNI)
angiotensin-converting enzyme inhibitor (ACEI)
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (STEMI) than enalapril.


Eligibility criteria: 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

Primary outcomes:
measure: LV remodeling index on CMR
timeFrame: 6 months
Secondary outcomes:
measure: left ventricular (LV) ejection fraction
timeFrame: 6 months
measure: global peak LV longitudinal strain
timeFrame: 6 months
measure: myocardial fibrosis
timeFrame: 6 months
measure: Time to the first occurrence of a composite endpoint of adverse clinical events
timeFrame: up to approximately 60 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
citation: Diao K, Wang D, Chen Z, Wu X, Ma M, Zhu Y, Zhang L, Wang H, Wang M, He S, Li C, Deng Q, Yan T, Wu T, Tang L, Huang B, Sun J, He Y. Rationale and design of a multi-center, prospective randomized controlled trial on the effects of sacubitril-valsartan versus enalapril on left ventricular remodeling in ST-elevation myocardial infarction: The PERI-STEMI study. Clin Cardiol. 2021 Dec;44(12):1709-1717. doi: 10.1002/clc.23744. Epub 2021 Oct 20.