Acute Coronary SyndromeNCT06321094
Effect of Vericiguat on Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%
An observational study of Acute Coronary Syndrome and Heart Failure With Reduced Ejection Fraction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection <45% between participants who take vericiguat regularly and those who donot. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure With Reduced Ejection Fraction
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 1 Dec 2025
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people who meet the eligibility criteria
Who may be able to join
- 1.Provide written informed consent for the trial.
- 2.Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]).
- 3.ejection fraction <45%.
- 4.Be male or female, aged greater than18 and less than 90 on the day of signing informed consent.
Who cannot join
- 1.SBP<100mmHg.
- 2.Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial.
- 3.Has severe hepatic insufficiency or renal insufficiency.
- 4.Has malignancy or other non-cardiac condition limiting life expectancy to <1 years.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: Vericiguat in Patients With Acute Coronary Syndrome and Reduced Ejection Fraction: The EVE-ACSrEF Study
Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection <45% between participants who take vericiguat regularly and those who donot.
Read the detailed description
Vericiguat, a novel soluble guanylate cyclase stimulator, reduced the incidence of cardiovascular death or hospitalization for HF in a population of high-risk patients with heart failure with reduced ejection fraction （HFrEF ）who had recently been hospitalized or received intravenous diuretic therapy.Given the increasing incidence of patients with ACS and its challenges posing to life，investigators intend to conduct a prospective observational study. Investigators choose several meaningful endpoints including the time of cardiovascular death or heart failure（HF) hospitalization、inflammatory markers、the value of N-terminal pro-B-type natriuretic peptide(NT-proBNP)、results of echocardiogram and life quality score.By collecting these datas and work on a group of analysis ，investigators evaluate whether differences exsit in ACS patients with ejection <45% between participants who take vericiguat regularly and those who donot.
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who take vericiguat | Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)<45% are to take vericiguat. | |
| patients who donot take vericiguat | Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)<45% arenot to take vericiguat. |
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite of death from cardiovascular causes or first hospitalization for heart failure
Measured: from baseline to one year
Secondary outcomes (3)
results of echocardiogram
changes in left ventricular ejection fraction during the follow-up
Measured: from baseline to one year
the numerical value of NT-proBNP
an important biomarker of heart failure
Measured: from baseline to one year
life quality score
Investigators choose Kansas City Cardiomyopathy Questionnaire(KCCQ) to evaluate life quality of participants.
Measured: from baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start31 Jan 2024
- Primary completion1 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321094
- Sponsor's protocol ID
- EVE-ACSrEF
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
PubMed 32222134Saldarriaga C, Atar D, Stebbins A, Lewis BS, Abidin IZ, Blaustein RO, Butler J, Ezekowitz JA, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Ponikowski P, Roessig L, Voors AA, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Vericiguat in patients with coronary artery disease and heart failure with reduced ejection fraction. Eur J Heart Fail. 2022 May;24(5):782-790. doi: 10.1002/ejhf.2468. Epub 2022 Mar 20.
PubMed 35239245Ponikowski P, Alemayehu W, Oto A, Bahit MC, Noori E, Patel MJ, Butler J, Ezekowitz JA, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Roessig L, Voors AA, Westerhout C, Armstrong PW; VICTORIA Study Group. Vericiguat in patients with atrial fibrillation and heart failure with reduced ejection fraction: insights from the VICTORIA trial. Eur J Heart Fail. 2021 Aug;23(8):1300-1312. doi: 10.1002/ejhf.2285. Epub 2021 Jul 18.
PubMed 34191395Chen T, Kong B, Shuai W, Gong Y, Zhang J, Huang H. Vericiguat alleviates ventricular remodeling and arrhythmias in mouse models of myocardial infarction via CaMKII signaling. Life Sci. 2023 Dec 1;334:122184. doi: 10.1016/j.lfs.2023.122184. Epub 2023 Oct 20.
PubMed 37866806Shi X, Zhao A, Ding Y, Gu L, Yang T, Wang H, Wang Q, Wang S, Wang L. Vericiguat in patients with acute coronary syndrome and reduced ejection fraction: the EVE-ACSrEF study. BMC Cardiovasc Disord. 2026 Feb 21;26(1):262. doi: 10.1186/s12872-026-05622-1.
PubMed 41723351
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vericiguat in Patients With Acute Coronary Syndrome and Reduced Ejection Fraction: The EVE-ACSrEF Study
- ClinicalTrials.gov ID
- NCT06321094
- Acronym / sponsor ID
- EVE-ACSrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 Mar 2024 (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.
Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection <45% between participants who take vericiguat regularly and those who donot.
Detailed description
Vericiguat, a novel soluble guanylate cyclase stimulator, reduced the incidence of cardiovascular death or hospitalization for HF in a population of high-risk patients with heart failure with reduced ejection fraction （HFrEF ）who had recently been hospitalized or received intravenous diuretic therapy.Given the increasing incidence of patients with ACS and its challenges posing to life，investigators intend to conduct a prospective observational study. Investigators choose several meaningful endpoints including the time of cardiovascular death or heart failure（HF) hospitalization、inflammatory markers、the value of N-terminal pro-B-type natriuretic peptide(NT-proBNP)、results of echocardiogram and life quality score.By collecting these datas and work on a group of analysis ，investigators evaluate whether differences exsit in ACS patients with ejection <45% between participants who take vericiguat regularly and those who donot.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who take vericiguat | – | –Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)<45% are to take vericiguat. |
| patients who donot take vericiguat | – | –Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)<45% arenot to take vericiguat. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people who meet the eligibility criteria
Key inclusion criteria (4 listed)
- 1.Provide written informed consent for the trial.
- 2.Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]).
- 3.ejection fraction <45%.
- 4.Be male or female, aged greater than18 and less than 90 on the day of signing informed consent.
Key exclusion criteria (4 listed)
- 1.SBP<100mmHg.
- 2.Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial.
- 3.Has severe hepatic insufficiency or renal insufficiency.
- 4.Has malignancy or other non-cardiac condition limiting life expectancy to <1 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
a composite of death from cardiovascular causes or first hospitalization for heart failure
Time frame: from baseline to one year
3 secondary outcomes
results of echocardiogram
Time frame: from baseline to one year
the numerical value of NT-proBNP
Time frame: from baseline to one year
life quality score
Time frame: from baseline to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Results publication: PubMed 32222134Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
- Results publication: PubMed 35239245Saldarriaga C, Atar D, Stebbins A, Lewis BS, Abidin IZ, Blaustein RO, Butler J, Ezekowitz JA, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Ponikowski P, Roessig L, Voors AA, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Vericiguat in patients with coronary artery disease and heart failure with reduced ejection fraction. Eur J Heart Fail. 2022 May;24(5):782-790. doi: 10.1002/ejhf.2468. Epub 2022 Mar 20.
- Results publication: PubMed 34191395Ponikowski P, Alemayehu W, Oto A, Bahit MC, Noori E, Patel MJ, Butler J, Ezekowitz JA, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Roessig L, Voors AA, Westerhout C, Armstrong PW; VICTORIA Study Group. Vericiguat in patients with atrial fibrillation and heart failure with reduced ejection fraction: insights from the VICTORIA trial. Eur J Heart Fail. 2021 Aug;23(8):1300-1312. doi: 10.1002/ejhf.2285. Epub 2021 Jul 18.
- Results publication: PubMed 37866806Chen T, Kong B, Shuai W, Gong Y, Zhang J, Huang H. Vericiguat alleviates ventricular remodeling and arrhythmias in mouse models of myocardial infarction via CaMKII signaling. Life Sci. 2023 Dec 1;334:122184. doi: 10.1016/j.lfs.2023.122184. Epub 2023 Oct 20.
- Derived from this study: PubMed 41723351Shi X, Zhao A, Ding Y, Gu L, Yang T, Wang H, Wang Q, Wang S, Wang L. Vericiguat in patients with acute coronary syndrome and reduced ejection fraction: the EVE-ACSrEF study. BMC Cardiovasc Disord. 2026 Feb 21;26(1):262. doi: 10.1186/s12872-026-05622-1.
- Individual participant dataSharing planned: No
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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?
An observational study of Acute Coronary Syndrome and Heart Failure With Reduced Ejection Fraction, run by The First Affiliated Hospital with Nanjing Medical University 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 4 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: finished, as of the sponsor's last update on 24 Dec 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
a composite of death from cardiovascular causes or first hospitalization for heart failure (time frame: from baseline to one year). 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 NCT06321094, which also lists 5 linked publications.
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 24 Dec 2025.