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Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

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

NCT05060588•Qingdao Central Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension.
•3. 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

•1. Patients with severe renal dysfunction. (GFR\<60mmol/L).
•2. Patients who have recently undergone immunosuppressive therapy.
•3. Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan.
•4. Patients who are hemodynamically unstable.
•5. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %).
•6. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
•7. 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.
•8. Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Locations (1)

Mengmei Li

Qingdao, Shandong, China

Key Dates

Start Date

October 1, 2021

Primary Completion Date

October 1, 2022

Completion Date

February 1, 2023

Last Updated

September 29, 2021

Enrollment

200

ESTIMATED participants

Conditions

Myocardial InfarctionHypertension

Interventions

Sacubitril/Valsartan 49/51mg/Tab

DRUG

Valsartan 80mg/Tab

DRUG

Contacts

Mengmei Li, MD

CONTACT

0086053284961672 sjogen@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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