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

Phase 4

Recruiting

• Conditions: Acute Coronary Syndrome; Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: Vericiguat

• Registration Number: NCT06321094
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients who take vericiguat	Vericiguat	ACS patients with ejection fraction(EF)\<45% are required to take vericiguat according to the guidelines from 2.5mg once a day to 5mg after two weeks.

Primary Outcome Measures

Name	Time	Method
a composite of death from cardiovascular causes or first hospitalization for heart failure	from baseline to one year

Secondary Outcome Measures

Name	Time	Method
interleukin-6 level	from baseline to one year	an indicator of inflammatory infection
life quality score	from baseline to one year	Investigators choose Kansas City Cardiomyopathy Questionnaire(KCCQ) to evaluate life quality of participants.
the numerical value of NT-proBNP	from baseline to one year	an important biomarker of heart failure
results of echocardiogram	from baseline to one year	key indicators include ejection fraction、cardiac output、systolic volume
level of procalcitonin	from baseline to one year	reflect the active degree of systemic inflammatory resonse

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China