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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
376
After initiation of the treatment of sacubitril/valsartan, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (24/26 mg, 49/51 mg and 97/103 mg, twice daily)
After initiation of the treatment of enalapril, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (2.5 mg, 5 mg, and 10 mg,twice daily)
For patients who were previously treated with ACEI and receiving the last dose of that agent during the last 36 hours prior to randomization, Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day was used.
West China Hospital
Chengdu, Sichuan, China
LV remodeling index on CMR
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
Time frame: 6 months
left ventricular (LV) ejection fraction
left ventricular ejection fraction indexes at the 6-month CMR.
Time frame: 6 months
global peak LV longitudinal strain
global peak LV longitudinal strain at the 6-month CMR.
Time frame: 6 months
myocardial fibrosis
extracelluar volume measured through T1 mapping sequence at the 6-month CMR.
Time frame: 6 months
Time to the first occurrence of a composite endpoint of adverse clinical events
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)
Time frame: up to approximately 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.