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

NCT04912167 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: WestChinaH-CVD-003
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI

Keywords

ST-elevation myocardial infarction (STEMI); cardiovascular magnetic resonance (CMR); angiotensin receptor neprilysin inhibitor (ARNI); angiotensin-converting enzyme inhibitor (ACEI)

Outcome Measures

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

  6 months

Secondary Outcomes (4)

• left ventricular (LV) ejection fraction

  6 months

• global peak LV longitudinal strain

  6 months

• myocardial fibrosis

  6 months

• Time to the first occurrence of a composite endpoint of adverse clinical events

  up to approximately 60 months

Study Arms (2)

ARNI-Sacubitril-Valsartan

EXPERIMENTAL

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; Drug: Valsartan

ACEI-Enalapril

ACTIVE COMPARATOR

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

Drug: Enalapril

Interventions

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)

ARNI-Sacubitril-Valsartan

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)

ACEI-Enalapril

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.

ARNI-Sacubitril-Valsartan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 621000, China

Location

Related Publications (1)

• 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.

  PMID: 34668596 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

sacubitril and valsartan sodium hydrate drug combination; Enalapril; Valsartan

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 3, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

CN (1)