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

Acute Coronary Syndrome Clinical Trial

Official title:

Effect of Vericiguat on Endpoint Events in ACS Patients With Ejection Fraction <45%：a Prospective Preventional Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321094
• Other study ID #: VERI-ACS
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: LianSheng Wang
• Phone: 13390787111
• Email: drlswang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Heart Failure With Reduced Ejection Fraction
• Syndrome

Intervention

Drug:
• Vericiguat
Investigators divide our participants into two groups ;one group is required to take vericiguat,and the other isnot required to take vericiguat.Expect this,no intervention is used in the research.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & 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 F — View Citation

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 2 — View Citation

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 — View Citation

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 coro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a composite of death from cardiovascular causes or first hospitalization for heart failure		from baseline to one year
Secondary	results of echocardiogram	key indicators include ejection fraction?cardiac output?systolic volume	from baseline to one year
Secondary	the numerical value of NT-proBNP	an important biomarker of heart failure	from baseline to one year
Secondary	level of procalcitonin	reflect the active degree of systemic inflammatory resonse	from baseline to one year
Secondary	interleukin-6 level	an indicator of inflammatory infection	from baseline to one year
Secondary	life quality score	Investigators choose Kansas City Cardiomyopathy Questionnaire(KCCQ) to evaluate life quality of participants.	from baseline to one year