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

Sponsor

Qingdao Central Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05060588

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Hypertension	Drug: Sacubitril/Valsartan 49/51mg/Tab Drug: Valsartan 80mg/Tab	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Sacubitril/Valsartan

Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months

Drug: Sacubitril/Valsartan 49/51mg/Tab

patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months

Other Names:

Sacubitril/Valsartan Group

Active Comparator: Valsartan

1 tablet of Valsartan every 24 hours for 6 months

Drug: Valsartan 80mg/Tab

Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.

Other Names:

Valsartan Group

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.