NCT06321094

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

March 6, 2024

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • a composite of death from cardiovascular causes or first hospitalization for heart failure

    from baseline to one year

Secondary Outcomes (3)

  • results of echocardiogram

    from baseline to one year

  • the numerical value of NT-proBNP

    from baseline to one year

  • life quality score

    from baseline to one year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people who meet the eligibility criteria

You may qualify if:

  • Provide written informed consent for the trial.
  • 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 \[PCI\]).
  • ejection fraction \<45%.
  • Be male or female, aged greater than18 and less than 90 on the day of signing informed consent.

You may not qualify if:

  • SBP\<100mmHg.
  • Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial.
  • Has severe hepatic insufficiency or renal insufficiency.
  • Has malignancy or other non-cardiac condition limiting life expectancy to \<1 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 20, 2024

Study Start

January 31, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

December 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations