Myocardial InfarctionPhase 4NCT05060588
Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction
A Phase 4 study testing Sacubitril/Valsartan 49/51mg/Tab and Valsartan 80mg/Tab in people with Myocardial Infarction and Hypertension, run by Qingdao Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Hypertension
- What is being tested?
- Sacubitril/Valsartan 49/51mg/Tab and Valsartan 80mg/Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Mengmei Li
Qingdao, Shandong, 266042
Jun Teng, MD, 0086053284961819, owen-145@163.com
About this study
Official title: 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.
- Conditions
- Myocardial Infarction, Hypertension
- Being tested
- Sacubitril/Valsartan 49/51mg/Tab, Valsartan 80mg/Tab
- Keywords
- Sacubitril/Valsartan, Valsartan, Myocardial Infarction, Hypertension
- Medical subject headings
- Myocardial Infarction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/Valsartan 49/51mg/TabDrug
Also called Sacubitril/Valsartan Group
patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
Valsartan 80mg/TabDrug
Also called Valsartan Group
Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan | Experimental | Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months Receives: Drug: Sacubitril/Valsartan 49/51mg/Tab |
| Valsartan | Active comparator | 1 tablet of Valsartan every 24 hours for 6 months Receives: Drug: Valsartan 80mg/Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (4)
Left ventricular ejection fraction(LVEF) by echocardiography
Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Teng, MD, Study director, Qingdao Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060588
- Sponsor's protocol ID
- Sacu-HPT
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05060588
- Acronym / sponsor ID
- Sacu-HPT
- Conditions
- Myocardial Infarction, Hypertension
- Keywords
- Sacubitril/Valsartan, Valsartan, Myocardial Infarction, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan | Experimental | Drug: Sacubitril/Valsartan 49/51mg/TabSacubitril/Valsartan 24/26 mg once every 12 hours for 6 months |
| Valsartan | Active comparator | Drug: Valsartan 80mg/Tab1 tablet of Valsartan every 24 hours for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 %).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril/Valsartan 49/51mg/TabAlso: Sacubitril/Valsartan Grouppatients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months | Drug | Sacubitril/Valsartan |
| Valsartan 80mg/TabAlso: Valsartan GroupPatients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months. | Drug | Valsartan |
Primary outcome
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.
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
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
4 secondary outcomes
Left ventricular ejection fraction(LVEF) by echocardiography
Time frame: 6 months
Rate of post infarction angina by following up in the clinic
Time frame: 6 months
The rate of heart failure occurrence by following up in the clinic
Time frame: 6 months
Left ventricular end-diastolic volume(LVEDV) by echocardiography
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Teng, MD study director
Qingdao Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril/Valsartan 49/51mg/Tab and Valsartan 80mg/Tab in people with Myocardial Infarction and Hypertension, run by Qingdao Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengmei Li, MD (0086053284961672, sjogen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MACE events no.1 by phone calls and questionnaires (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.