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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-02-28

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.

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Detailed Description

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Conditions

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Myocardial Infarction Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sacubitril/Valsartan

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

Group Type EXPERIMENTAL

Sacubitril/Valsartan 49/51mg/Tab

Intervention Type DRUG

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

Valsartan

1 tablet of Valsartan every 24 hours for 6 months

Group Type ACTIVE_COMPARATOR

Valsartan 80mg/Tab

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Valsartan 80mg/Tab

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

Intervention Type DRUG

Other Intervention Names

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Sacubitril/Valsartan Group Valsartan Group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No