Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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Studies have demonstrated that the early initiation of ACEI/ARB to patients with acute myocardial infarction is beneficial, especially in patients combined with reduced LVEF or mild-moderate heart failure. Therefore, ACEI/ARB is a traditional treatment for patients post-infarction. Recent clinical trials have demonstrated that Sacubitril/Valsartan is more beneficial than Ramipril to patients post-PCI.Besides, Sacubitril/Valsartan is also effective for essential hypertension.This study aims to assess the effect of Sacubitril/Valsartan on short-term prognosis in hypertensive patients with acute myocardial infarction compared against Valsartan.

Official Title
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The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction, Hypertension

Intervention / Treatment
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* Drug: Sacubitril/Valsartan 49/51mg/Tab
* Drug: Valsartan 80mg/Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with new-onset MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days. Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol. Exclusion Criteria: Patients with severe renal dysfunction. (GFR<60mmol/L). Patients who have recently undergone immunosuppressive therapy. Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan. Patients who are hemodynamically unstable. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %). Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial. Any non-CV condition, such as active malignancy requiring treatment at the time of screening, or severe diseases with a life expectancy of fewer than two years based on the investigator´s clinical judgment. Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacubitril/Valsartan<br>Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months | Drug: Sacubitril/Valsartan 49/51mg/Tab<br>* patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months<br>* Other names: Sacubitril/Valsartan Group;|
| Active Comparator: Valsartan<br>1 tablet of Valsartan every 24 hours for 6 months | Drug: Valsartan 80mg/Tab<br>* Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.<br>* Other names: Valsartan Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MACE events no.1 by phone calls and questionnaires | To assess the rate of myocardial infarction in post-infarction patients during the study follow-up. | 6 months | 
| Rate of MACE events No.2 by phone calls and questionnaires | To assess the rate of stroke in patients post-MI during the follow up period | 6 months | 
| Rate of MACE events No.3 phone calls and questionnaires | To assess the rate of death from cardiovascular causes during the follow up time | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction(LVEF) by echocardiography | Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment. | 6 months | 
| Rate of post infarction angina by following up in the clinic | Evaluate the Effect of Sacubitril/Valsartan versus Valsartan on the development of post-infarction angina. | 6 months | 
| The rate of heart failure occurrence by following up in the clinic | Assess the occurence of heart failure during the study follow-up. | 6 months | 
| Left ventricular end-diastolic volume(LVEDV) by echocardiography | Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacubitril/Valsartan, Valsartan, Myocardial Infarction, Hypertension