Effect of Vericiguat on Acute Coronary Syndrome( ACS)Patients With Ejection Fraction <45%
Vericiguat in Patients With Acute Coronary Syndrome and Reduced Ejection Fraction: The EVE-ACSrEF Study
1 other identifier
observational
149
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2024
CompletedFirst Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 24, 2025
February 1, 2025
1.7 years
March 6, 2024
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
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
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.
PMID: 32222134RESULTSaldarriaga 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.
PMID: 35239245RESULTPonikowski 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.
PMID: 34191395RESULTChen 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.
PMID: 37866806RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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