Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT05487560
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding
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': 4133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of total Major Adverse CardioCerebrovascular Events(MACCE) from baseline', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The incidence of MACCE by each of the following constituent variables', 'timeFrame': '6 months', 'description': 'MACCE: Death due to cardiovascular abnormalities, myocardial infarction, stroke (ischemic or hemorrhagic), Target vessel reperfusion (in case of repeated intervention or coronary artery bypass surgery), All other cardiovascular events requiring hospitalization'}, {'measure': 'The incidence e of Major bleeding', 'timeFrame': '6 months', 'description': 'Major bleeding: intracranial hemorrhage, bleeding requiring a transfusion or A decrease in hemoglobin level ≥ 5 g/dL or a decrease in hematocrit ≥ 15%'}, {'measure': 'The incidence of Minor bleeding', 'timeFrame': '6 months', 'description': 'Minor bleeding: Any bleeding other than major bleeding'}, {'measure': 'The incidence of GI Bleeding', 'timeFrame': '6 months', 'description': 'GI Bleeding: hematemesis, melena/hematochezia, Fecal Occult Blood Test, FOBT'}, {'measure': 'Occurrence and aspect of adverse events(AEs)', 'timeFrame': '6 months'}, {'measure': 'Medication compliance evaluation', 'timeFrame': '6 months'}, {'measure': 'Drug administration dose of DAPT(Clopidogrel + Aspirin) and Esomezol Cap', 'timeFrame': 'baseline'}, {'measure': 'Drugs that are prescribed in combination other than DAPT(Clopidogrel + Aspirin) and Esomezol Cap for the treatment of patients with acute coronary syndrome or cerebral infarction', 'timeFrame': 'baseline'}, {'measure': 'Add-on drugs for the treatment of patients with acute coronary syndrome or cerebral infarction', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for the prevention of gastrointestinal bleeding.', 'detailedDescription': "This study was a multi-center, prospective, non-interventional, observational study of administering Esomezol Cap for the purpose of preventing gastrointestinal bleeding.\n\nData was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the safety of Esomezol Cap.\n\nThis study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute Coronary Syndrome or B Cerebral Infarction requiring DAPT (Clopidogrel + Aspirin) for at least 6 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥19\n2. Among patients who visited the hospital due to the onset or recurrence of acute coronary syndrome or cerebral infarction within 1 month prior to registration, patients who are expected to receive DAPT(Clopidogrel + Aspirin) for at least 6 months, in combination with Esomezol Cap for the purpose of preventing gastrointestinal bleeding Patients receiving or planning to receive treatment\n3. Subject who can written informed consent voluntarily\n\nExclusion Criteria:\n\n1\\) Patients for whom use of Esomezol Cap is prohibited'}, 'identificationModule': {'nctId': 'NCT05487560', 'briefTitle': 'An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Multi-center, Prospective Cohort, Observational Study to Evaluate the Incidence of Major Adverse Cardiocerebrovascular Events According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received Dual AntiPlatelet Therapy (DAPT) for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding', 'orgStudyIdInfo': {'id': 'HM-ESO-OS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '12-hour interval group (No interventional)', 'description': 'DAPT(Clopidogrel + Aspirin) and Esomezol Cap taken every 12 hours', 'interventionNames': ['Drug: Esomezol Cap']}, {'label': 'co-administration group (No interventional)', 'description': 'Taking DAPT(Clopidogrel + Aspirin) and Esomezol Cap at the same time', 'interventionNames': ['Drug: Esomezol Cap']}], 'interventions': [{'name': 'Esomezol Cap', 'type': 'DRUG', 'description': 'Esomezol Cap, Once daily administered per the locally approved product information', 'armGroupLabels': ['12-hour interval group (No interventional)', 'co-administration group (No interventional)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05545', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanmi Pharmaceutical Company Limited', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}