Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 4:40 PM
Study NCT ID:
NCT06321094
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2024-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vericiguat on Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-17', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a composite of death from cardiovascular causes or first hospitalization for heart failure', 'timeFrame': 'from baseline to one year'}], 'secondaryOutcomes': [{'measure': 'results of echocardiogram', 'timeFrame': 'from baseline to one year', 'description': 'changes in left ventricular ejection fraction during the follow-up'}, {'measure': 'the numerical value of NT-proBNP', 'timeFrame': 'from baseline to one year', 'description': 'an important biomarker of heart failure'}, {'measure': 'life quality score', 'timeFrame': 'from baseline to one year', 'description': 'Investigators choose Kansas City Cardiomyopathy Questionnaire(KCCQ) to evaluate life quality of participants.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Heart Failure With Reduced Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '32222134', 'type': 'RESULT', 'citation': "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': '35239245', 'type': 'RESULT', '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 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': '34191395', 'type': 'RESULT', '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 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': '37866806', 'type': 'RESULT', '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 20.'}]}, 'descriptionModule': {'briefSummary': 'Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection \\<45% between participants who take vericiguat regularly and those who donot.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people who meet the eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Provide written informed consent for the trial.\n* 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\\]).\n* 3.ejection fraction \\<45%.\n* 4.Be male or female, aged greater than18 and less than 90 on the day of signing informed consent.\n\nExclusion Criteria.\n\n* 1.SBP\\<100mmHg.\n* 2.Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial.\n* 3.Has severe hepatic insufficiency or renal insufficiency.\n* 4.Has malignancy or other non-cardiac condition limiting life expectancy to \\<1 years.'}, 'identificationModule': {'nctId': 'NCT06321094', 'briefTitle': 'Effect of Vericiguat on Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Vericiguat in Patients With Acute Coronary Syndrome and Reduced Ejection Fraction: The EVE-ACSrEF Study', 'orgStudyIdInfo': {'id': 'EVE-ACSrEF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients who take vericiguat', 'description': 'Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)\\<45% are to take vericiguat.'}, {'label': 'patients who donot take vericiguat', 'description': 'Grouped by their treatment preference, some of ACS patients with ejection fraction(EF)\\<45% arenot to take vericiguat.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'the First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}