STEMIPhase 3PERI-STEMINCT04912167
The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
A Phase 3 study testing Sacubitril-Valsartan, Enalapril and Valsartan in people with STEMI, run by West China Hospital at 1 site in China.
Trial summary
The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with ST-elevation myocardial infarction (STEMI) than enalapril. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- STEMI
- What is being tested?
- Sacubitril-Valsartan, Enalapril and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- Nov 2021to Jun 2026
- Phase
- Phase 3
- 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
- Aged between 18 - 75 years old
- First-time ST-segment elevation myocardial infarction based on the newest ESC guidelines
- Timely primary percutaneous coronary intervention within 12 hours from onset
- Written informed consent acquired
Who cannot join
- Known history of or persistent clinical chronic heart failure prior to randomization
- Previous use of ARNI, or intolerance or contraindications to study drugs including ARNI or ACEI
- History of significant chronic coronary obstruction and adverse ventricular remodeling
- History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent or CABG, or planned open-heart surgery within 3 months
- History of hepatic impairment or history of cirrhosis with evidence of portal hypertension
- History of chronic renal dysfunction, or eGFR < 30 ml/min/1.73 m2
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- History of malignancy and with a life span less than one year
- Patients with a known history of angioedema related to previous ACEIs/ARB therapy.
- With contraindication to MRI examination (pacemaker and claustrophobia) or cannot finish breath-holding when lying on the examination bed
- Pregnancy or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective Randomized Controlled Trial on the Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with ST-elevation myocardial infarction (STEMI) than enalapril.
- Conditions
- STEMI
- Being tested
- Sacubitril-Valsartan, Enalapril, Valsartan
- Keywords
- ST-elevation myocardial infarction (STEMI), cardiovascular magnetic resonance (CMR), angiotensin receptor neprilysin inhibitor (ARNI), angiotensin-converting enzyme inhibitor (ACEI)
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-ValsartanDrug
After initiation of the treatment of sacubitril/valsartan, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (24/26 mg, 49/51 mg and 97/103 mg, twice daily)
EnalaprilDrug
After initiation of the treatment of enalapril, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (2.5 mg, 5 mg, and 10 mg,twice daily)
ValsartanDrug
For patients who were previously treated with ACEI and receiving the last dose of that agent during the last 36 hours prior to randomization, Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day was used.
| Study group | Role | What they receive |
|---|---|---|
| ARNI-Sacubitril-Valsartan | Experimental | patients randomized to angiotensin receptor neprilysin inhibitor (ARNI) group will receive 2 doses of angiotensin receptor blocker (ARB) to ensure a minimum 36-hour washout period prior to initiation of ARNI therapy, and then be started with the first dose or sacubitril-valsartan. Receives: Drug: Sacubitril-Valsartan; Drug: Valsartan |
| ACEI-Enalapril | Active comparator | patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV remodeling index on CMR
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
Measured: 6 months
Secondary outcomes (4)
left ventricular (LV) ejection fraction
left ventricular ejection fraction indexes at the 6-month CMR.
Measured: 6 months
global peak LV longitudinal strain
global peak LV longitudinal strain at the 6-month CMR.
Measured: 6 months
myocardial fibrosis
extracelluar volume measured through T1 mapping sequence at the 6-month CMR.
Measured: 6 months
Time to the first occurrence of a composite endpoint of adverse clinical events
including all deaths (cardiac death vs non-cardiac death), non-fatal myocardial re-infarction, hospitalization for worsening heart failure or need for advanced HF therapies (hospital stay > 24 hours)(e.g., intravenous use of inotropes, left ventricular assist device placement, or cardiac transplantation)
Measured: up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study startNov 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912167
- Sponsor's protocol ID
- WestChinaH-CVD-003
- Acronym
- PERI-STEMI
- Status last verified
- Sep 2021
- First submitted
- 26 May 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Diao K, Wang D, Chen Z, Wu X, Ma M, Zhu Y, Zhang L, Wang H, Wang M, He S, Li C, Deng Q, Yan T, Wu T, Tang L, Huang B, Sun J, He Y. Rationale and design of a multi-center, prospective randomized controlled trial on the effects of sacubitril-valsartan versus enalapril on left ventricular remodeling in ST-elevation myocardial infarction: The PERI-STEMI study. Clin Cardiol. 2021 Dec;44(12):1709-1717. doi: 10.1002/clc.23744. Epub 2021 Oct 20.
PubMed 34668596
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
- A Multi-center, Prospective Randomized Controlled Trial on the Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04912167
- Acronym / sponsor ID
- PERI-STEMI / WestChinaH-CVD-003
- Conditions
- STEMI
- Keywords
- ST-elevation myocardial infarction (STEMI), cardiovascular magnetic resonance (CMR), angiotensin receptor neprilysin inhibitor (ARNI), angiotensin-converting enzyme inhibitor (ACEI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Jun 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.
The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with ST-elevation myocardial infarction (STEMI) than enalapril.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARNI-Sacubitril-Valsartan | Experimental | Drug: Sacubitril-Valsartan, Drug: Valsartanpatients randomized to angiotensin receptor neprilysin inhibitor (ARNI) group will receive 2 doses of angiotensin receptor blocker (ARB) to ensure a minimum 36-hour washout period prior to initiation of ARNI therapy, and then be started with the first dose or sacubitril-valsartan. |
| ACEI-Enalapril | Active comparator | Drug: Enalaprilpatients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 - 75 years old
- First-time ST-segment elevation myocardial infarction based on the newest ESC guidelines
- Timely primary percutaneous coronary intervention within 12 hours from onset
- Written informed consent acquired
Key exclusion criteria (10 listed)
- Known history of or persistent clinical chronic heart failure prior to randomization
- Previous use of ARNI, or intolerance or contraindications to study drugs including ARNI or ACEI
- History of significant chronic coronary obstruction and adverse ventricular remodeling
- History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent or CABG, or planned open-heart surgery within 3 months
- History of hepatic impairment or history of cirrhosis with evidence of portal hypertension
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-ValsartanAfter initiation of the treatment of sacubitril/valsartan, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (24/26 mg, 49/51 mg and 97/103 mg, twice daily) | Drug | ARNI-Sacubitril-Valsartan |
| EnalaprilAfter initiation of the treatment of enalapril, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (2.5 mg, 5 mg, and 10 mg,twice daily) | Drug | ACEI-Enalapril |
| ValsartanFor patients who were previously treated with ACEI and receiving the last dose of that agent during the last 36 hours prior to randomization, Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day was used. | Drug | ARNI-Sacubitril-Valsartan |
Primary outcome
LV remodeling index on CMR
Time frame: 6 months
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
4 secondary outcomes
left ventricular (LV) ejection fraction
Time frame: 6 months
global peak LV longitudinal strain
Time frame: 6 months
myocardial fibrosis
Time frame: 6 months
Time to the first occurrence of a composite endpoint of adverse clinical events
Time frame: up to approximately 60 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.
- Derived from this study: PubMed 34668596Diao K, Wang D, Chen Z, Wu X, Ma M, Zhu Y, Zhang L, Wang H, Wang M, He S, Li C, Deng Q, Yan T, Wu T, Tang L, Huang B, Sun J, He Y. Rationale and design of a multi-center, prospective randomized controlled trial on the effects of sacubitril-valsartan versus enalapril on left ventricular remodeling in ST-elevation myocardial infarction: The PERI-STEMI study. Clin Cardiol. 2021 Dec;44(12):1709-1717. doi: 10.1002/clc.23744. Epub 2021 Oct 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sacubitril-Valsartan, Enalapril and Valsartan in people with STEMI, run by West China 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 4 inclusion and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV remodeling index on CMR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912167, which also lists 1 linked publication.
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.