The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction

NCT03893435 | Completed

• 1 other identifier: YIG01201902
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Sacubitril/Valsartan (SAC/VAL) is a new treatment of congestive heart failure (CHF) recently indicated as class I, level of evidence B in the recent European Society of Cardiology (ESC) guidelines 2016 of CHF. PARADIGM-HF trial demonstrated a significant improvement of morbidity and mortality with SAC/VAL in comparison to enalapril. So far, no data available about the effect of usage of SAC/VAL post-acute myocardial infarction (AMI) except in animal experimental models. The purpose of the research is evaluation of the effects of SAC/VAL in post-AMI in comparison to the traditional Angiotensin Converting Enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in a real-life clinical trial in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• One week major adverse cerebrovascular and cardiovascular events (MACCE)

  Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 1 week after AMI

  1 week after AMI

• Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE)

  Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 24 weeks after AMI

  24 weeks after AMI

• Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI.

  Change in the ejection fraction assessed by transthoracic echocardiography assessment (TTE) during hospital stay, 3 months and 6 months after AMI.

  In hospital, 3 months and 6 months after AMI

Study Arms (2)

Sacubitril/Valsartan

EXPERIMENTAL

In successfully revascularized post-AMI patients with LVEF ≤40% Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.

Drug: Sacubitril / Valsartan Oral Tablet [Entresto]

Valsartan

ACTIVE COMPARATOR

In successfully revascularized post-AMI patients with LVEF ≤40% Valsartan with an initial dose of 40 mg PO BID, with subsequent titrations to target maintenance dose of 160 mg BID as tolerated.

Drug: Sacubitril / Valsartan Oral Tablet [Entresto]

Interventions

Sacubitril / Valsartan Oral Tablet [Entresto] DRUG

Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.

Also known as: ARNI

Sacubitril/Valsartan; Valsartan

Eligibility Criteria

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

You may qualify if:

• Post-AMI patients who underwent successful PPCI and LVEF ≤40%.

You may not qualify if:

• Post-AMI patients who underwent successful PPCI and LVEF \>40%.
• History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
• Symptomatic hypotension and/or an SBP \< 100 mmHg.
• Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula or serum potassium \> 5.2 mmol/L.

Sponsors & Collaborators

• The Young Investigator Group of Cardiovascular Research: lead

Study Sites (1)

Andalusia Hospitals

Alexandria, 21524, Egypt

Location

MeSH Terms

Interventions

sacubitril; Valsartan; sacubitril and valsartan sodium hydrate drug combination

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sherif S Elbeltagui, MD

  Assisstant Professor of Cardiology, University of Alexandria, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar of Cardiology and Angiology

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 28, 2019
• Study Start: December 1, 2018
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)