Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT03051061
Status:
UNKNOWN
Last Update Posted:
2019-12-12
First Post:
2017-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-05-27', 'releaseDate': '2020-05-08'}, {'resetDate': '2020-06-29', 'releaseDate': '2020-06-16'}, {'resetDate': '2020-10-15', 'releaseDate': '2020-09-22'}, {'resetDate': '2021-03-11', 'releaseDate': '2021-02-19'}], 'estimatedResultsFirstSubmitDate': '2020-05-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thromboembolism', 'timeFrame': '1 year', 'description': 'including ischemic stroke and systemic embolization'}], 'secondaryOutcomes': [{'measure': 'Hemorrhage', 'timeFrame': '1 year', 'description': 'according to GUSTO criteria'}, {'measure': 'Major Adverse Cardiovascular Events(MACE)', 'timeFrame': '1 year', 'description': 'death, congestive heart failure, myocardial infarction'}, {'measure': 'A composite outcome', 'timeFrame': '1 year', 'description': 'including thromboembolism,hemorrhage,all cause death,congestive heart failure, myocardial infarction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Coronary Heart Disease', 'antithrombotic treatment', 'clinical prognosis'], 'conditions': ['Atrial Fibrillation', 'Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with Atrial Fibrillation (AF) is unresolved at present. Although the European and American guidelines have given a hand for us, there is absence of real-world data on the safety and efficacy of antithrombotic therapy in Asian populations. Only a few clinical trials are available to guide difficult decision on antithrombotic therapy in patients with combined AF and CHD，the investigators highlight the need for the rapid development of clinical trials to close the large gaps in evidence. This research aims to know the real-world use of antithrombotic treatment and clinical prognosis in Coronary Heart Disease patients complicated with Atrial Fibrillation.', 'detailedDescription': '1. Our study is an observational, retrospective Study.\n2. Key date elements and definition of each variable were in line with the American Heart Association(AHA)/European Society of Cardiology(ECS） recommendation on AF and CHD. To reflect the contemporary antithrombotic management of AF and CHD in the past five years, the following data were collected: basic socio-demographic information, symptoms and signs relating to AF, medical history, results of physical examination and laboratory test.\n3. Follow-up time is at least 12 months. The patients will be asked about their medications and clinical outcomes by telephone interview or outpatient clinic. Then we will analyze the relative safety and efficacy of the various antithrombotic regimens.\n4. Based on the largest prospective study by Denmark about this issue, we anticipate an 30% incidence of composite outcome in the triple therapy arm. To achieve a precision of 10% with an α=0.05 and the rate of defaulters is 10%. The final estimated sample size was 986.\n5. Henan institute of cardiology epidemiology is responsible for design, date quality control and statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with coexisting coronary heart disease and atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with chest pain and a significant lesion \\>50% angiographically.\n2. Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.\n\nExclusion Criteria:\n\n1. Rheumatic valvular disease.\n2. Contraindications to oral anticoagulation.\n3. Combined with other serious diseases with a life expectancy \\< 1 year.'}, 'identificationModule': {'nctId': 'NCT03051061', 'acronym': 'ACHDAF', 'briefTitle': 'Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Henan Institute of Cardiovascular Epidemiology'}, 'officialTitle': 'Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study', 'orgStudyIdInfo': {'id': 'HenanICE201604'}}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'You Zhang, PhD', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'You Zhang, PhD', 'role': 'CONTACT', 'email': '13598019682@126.com', 'phone': '+86 13598019682'}, {'name': 'Changyu Gao, PhD', 'role': 'CONTACT', 'email': 'gaocy6802@163.com', 'phone': '+86 13937165590'}], 'overallOfficials': [{'name': 'Changyu Gao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital"}, {'name': 'You Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital"}, {'name': 'Lili Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Henan Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Institute of Cardiovascular Epidemiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-05-08', 'type': 'RELEASE'}, {'date': '2020-05-27', 'type': 'RESET'}, {'date': '2020-06-16', 'type': 'RELEASE'}, {'date': '2020-06-29', 'type': 'RESET'}, {'date': '2020-09-22', 'type': 'RELEASE'}, {'date': '2020-10-15', 'type': 'RESET'}, {'date': '2021-02-19', 'type': 'RELEASE'}, {'date': '2021-03-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Henan Institute of Cardiovascular Epidemiology'}}}}