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

STEMI Clinical Trial

— PERI-STEMI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04912167
• Other study ID #: WestChinaH-CVD-003
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2021
• Est. completion date: June 2026

Study information

• Verified date: September 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 376
• Est. completion date: June 2026
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI
• Ventricular Remodeling

Intervention

Drug:
• Sacubitril-Valsartan
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)
• Enalapril
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)
• Valsartan
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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV remodeling index on CMR	change of the indexed LV mass (? LVmassi) from baseline to 6-month follow-up on CMR	6 months
Secondary	left ventricular (LV) ejection fraction	left ventricular ejection fraction indexes at the 6-month CMR.	6 months
Secondary	global peak LV longitudinal strain	global peak LV longitudinal strain at the 6-month CMR.	6 months
Secondary	myocardial fibrosis	extracelluar volume measured through T1 mapping sequence at the 6-month CMR.	6 months
Secondary	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)	up to approximately 60 months