Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-09 @ 9:51 AM
Study NCT ID:
NCT04162808
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleeding Risk Assessment System for Antithrombotic Therapy of ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6379}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-10', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of event of bleeding', 'timeFrame': '30 days', 'description': 'The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment'}, {'measure': 'The number of event of bleeding', 'timeFrame': '1 year', 'description': 'The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment'}], 'secondaryOutcomes': [{'measure': 'The number of event of bleeding', 'timeFrame': '30 days and 1 year', 'description': 'The number of event of bleeding (BARC 1 to 5) within 30 days and 1year after enrollment'}, {'measure': 'number of event of major adverse cardiovascular or cerebrovascular events', 'timeFrame': '30 days and 1 year', 'description': 'number of event of major adverse cardiovascular or cerebrovascular events within 30 days and 1year after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bleeding', 'antithrombosis'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ACS patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age18-85 years old\n2. Diagnosed ACS\n3. Signed informed consent form\n\nExclusion Criteria:\n\n1. Any active bleeding\n2. Not tolerate to anti-thrombotic drugs\n3. A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment\n4. Patients who died of non-bleeding causes within 24 hours after admission\n5. Noncardiac coexisting conditions that could limit life expectancy to less than 1 year\n6. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT04162808', 'briefTitle': 'Bleeding Risk Assessment System for Antithrombotic Therapy of ACS', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': '2018055X'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': 'Beijing Luhe Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Director, Emergency & Critical Care Center', 'investigatorFullName': 'Shao-Ping Nie', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}