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

September 23, 2021 updated by: Yong He, West China Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

376

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 621000
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARNI-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.
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: 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.
Active Comparator: ACEI-Enalapril
patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV remodeling index on CMR
Time Frame: 6 months
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular (LV) ejection fraction
Time Frame: 6 months
left ventricular ejection fraction indexes at the 6-month CMR.
6 months
global peak LV longitudinal strain
Time Frame: 6 months
global peak LV longitudinal strain at the 6-month CMR.
6 months
myocardial fibrosis
Time Frame: 6 months
extracelluar volume measured through T1 mapping sequence at the 6-month CMR.
6 months
Time to the first occurrence of a composite endpoint of adverse clinical events
Time Frame: 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)
up to approximately 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH-CVD-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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