NCT04912167

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

A Multi-center, Prospective Randomized Controlled Trial on the Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• STEMI

Interventions

Type	Name	Description
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)
DRUG	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)
DRUG	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-03-01
• Completion: 2026-06-01
• First posted: 2021-06-03
• Last updated: 2021-09-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study