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

Primary Purpose

STEMI

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sacubitril-Valsartan
Enalapril
Valsartan
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI focused on measuring ST-elevation myocardial infarction (STEMI), cardiovascular magnetic resonance (CMR), angiotensin receptor neprilysin inhibitor (ARNI), angiotensin-converting enzyme inhibitor (ACEI)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARNI-Sacubitril-Valsartan

ACEI-Enalapril

Arm Description

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.

patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril

Outcomes

Primary Outcome Measures

LV remodeling index on CMR
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR

Secondary Outcome Measures

left ventricular (LV) ejection fraction
left ventricular ejection fraction indexes at the 6-month CMR.
global peak LV longitudinal strain
global peak LV longitudinal strain at the 6-month CMR.
myocardial fibrosis
extracelluar volume measured through T1 mapping sequence at the 6-month CMR.
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)

Full Information

First Posted
May 26, 2021
Last Updated
September 23, 2021
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04912167
Brief Title
The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI
Keywords
ST-elevation myocardial infarction (STEMI), cardiovascular magnetic resonance (CMR), angiotensin receptor neprilysin inhibitor (ARNI), angiotensin-converting enzyme inhibitor (ACEI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARNI-Sacubitril-Valsartan
Arm Type
Experimental
Arm Description
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.
Arm Title
ACEI-Enalapril
Arm Type
Active Comparator
Arm Description
patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril
Intervention Type
Drug
Intervention Name(s)
Sacubitril-Valsartan
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
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.
Primary Outcome Measure Information:
Title
LV remodeling index on CMR
Description
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
Time Frame
6 months
Secondary Outcome Measure Information:
Title
left ventricular (LV) ejection fraction
Description
left ventricular ejection fraction indexes at the 6-month CMR.
Time Frame
6 months
Title
global peak LV longitudinal strain
Description
global peak LV longitudinal strain at the 6-month CMR.
Time Frame
6 months
Title
myocardial fibrosis
Description
extracelluar volume measured through T1 mapping sequence at the 6-month CMR.
Time Frame
6 months
Title
Time to the first occurrence of a composite endpoint of adverse clinical events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34668596
Citation
Diao K, Wang D, Chen Z, Wu X, Ma M, Zhu Y, Zhang L, Wang H, Wang M, He S, Li C, Deng Q, Yan T, Wu T, Tang L, Huang B, Sun J, He Y. Rationale and design of a multi-center, prospective randomized controlled trial on the effects of sacubitril-valsartan versus enalapril on left ventricular remodeling in ST-elevation myocardial infarction: The PERI-STEMI study. Clin Cardiol. 2021 Dec;44(12):1709-1717. doi: 10.1002/clc.23744. Epub 2021 Oct 20.
Results Reference
derived

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

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