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

ConditionSTEMI
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacubitril-Valsartan

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

376 Participants
are divided into 2 treatment groups
Group A: ARNI-Sacubitril-ValsartanExperimental treatment 2 interventions
Group B: ACEI-EnalaprilActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

left ventricular (LV) ejection fraction

left ventricular ejection fraction indexes at the 6-month CMR.

Time frame
6 months
2

global peak LV longitudinal strain

global peak LV longitudinal strain at the 6-month CMR.

Time frame
6 months
3

myocardial fibrosis

extracelluar volume measured through T1 mapping sequence at the 6-month CMR.

Time frame
6 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: