- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060588
Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction
September 18, 2021 updated by: Qingdao Central Hospital
The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mengmei Li, MD
- Phone Number: 0086053284961672
- Email: sjogen@163.com
Study Locations
-
-
Shandong
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Qingdao, Shandong, China, 266042
- Mengmei Li
-
Contact:
- Jun Teng, MD
- Phone Number: 0086053284961819
- Email: owen-145@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sacubitril/Valsartan
Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
|
patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
Other Names:
|
Active Comparator: Valsartan
1 tablet of Valsartan every 24 hours for 6 months
|
Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of MACE events no.1 by phone calls and questionnaires
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Assess the occurence of heart failure during the study follow-up.
|
6 months
|
Left ventricular end-diastolic volume(LVEDV) by echocardiography
Time Frame: 6 months
|
Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jun Teng, MD, Qingdao Central Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2021
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
February 1, 2023
Study Registration Dates
First Submitted
September 13, 2021
First Submitted That Met QC Criteria
September 18, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 18, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Hypertension
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Valsartan
- Sacubitril and valsartan sodium hydrate drug combination
Other Study ID Numbers
- Sacu-HPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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