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Effect of Vericiguat on Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%

NCT ID: NCT06321094

Last Updated: 2025-12-24

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

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome Heart Failure With Reduced Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients who take vericiguat

Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)\<45% are to take vericiguat.

No interventions assigned to this group

patients who donot take vericiguat

Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)\<45% arenot to take vericiguat.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 32222134 (View on PubMed)

Saldarriaga 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.

Reference Type RESULT
PMID: 35239245 (View on PubMed)

Ponikowski 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.

Reference Type RESULT
PMID: 34191395 (View on PubMed)

Chen 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.

Reference Type RESULT
PMID: 37866806 (View on PubMed)

Other Identifiers

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EVE-ACSrEF

Identifier Type: -

Identifier Source: org_study_id