The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
- Conditions
- STEMI
- Interventions
- Registration Number
- NCT04912167
- Lead Sponsor
- West China Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 376
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARNI-Sacubitril-Valsartan Sacubitril-Valsartan 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. ARNI-Sacubitril-Valsartan Valsartan 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. ACEI-Enalapril Enalapril patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril
- Primary Outcome Measures
Name Time Method LV remodeling index on CMR 6 months change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
- Secondary Outcome Measures
Name Time Method myocardial fibrosis 6 months extracelluar volume measured through T1 mapping sequence at the 6-month CMR.
Time to the first occurrence of a composite endpoint of adverse clinical events up to approximately 60 months including all deaths (cardiac death vs non-cardiac death), non-fatal myocardial re-infarction, hospitalization for worsening heart failure or need for advanced HF therapies (hospital stay \> 24 hours)(e.g., intravenous use of inotropes, left ventricular assist device placement, or cardiac transplantation)
left ventricular (LV) ejection fraction 6 months left ventricular ejection fraction indexes at the 6-month CMR.
global peak LV longitudinal strain 6 months global peak LV longitudinal strain at the 6-month CMR.
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China