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

March 17, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients who take 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.
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.
No Intervention: patients who donot take vericiguat
ACS patients with EF<45% arenot required to take vericiguat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
a composite of death from cardiovascular causes or first hospitalization for heart failure
Time Frame: from baseline to one year
from baseline to one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERI-ACS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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