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

Nanjing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Acute Coronary Syndrome; Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Vericiguat

Study type: Interventional

Funder types: Other

Identifiers

NCT06321094

VERI-ACS

Details and patient eligibility

About

Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection <45% between participants who take vericiguat regularly and those who donot.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

patients who take vericiguat

Experimental group

Description:

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.

Treatment:

Drug: Vericiguat

patients who donot take vericiguat

No Intervention group

Description:

ACS patients with EF\<45% arenot required to take vericiguat.