Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04255602
Status:
UNKNOWN
Last Update Posted:
2023-12-07
First Post:
2020-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2', 'timeFrame': 'Stent implantation to 12 months', 'description': 'a composite of death from coronary vascular causes,non-fatal myocardial infarction,stent thrombosis,coronary revascularization, stroke and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria'}], 'secondaryOutcomes': [{'measure': 'bleeding events of BARC grade ≥2', 'timeFrame': 'Stent implantation to 12 months', 'description': 'bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria'}, {'measure': 'a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke', 'timeFrame': 'Stent implantation to 12 months', 'description': 'a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Coronary Stent Implantation']}, 'referencesModule': {'references': [{'pmid': '35248132', 'type': 'DERIVED', 'citation': 'Pang Y, Ma M, Xia J, Wang D, YanChen, Ye J, Jia Z, Wu S, Yang J, Hou L. A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY. Trials. 2022 Mar 5;23(1):203. doi: 10.1186/s13063-022-06124-z.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg Aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for Chinese ACS patients compared with 90mg ticagrelor plus 100mg Aspirin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject must be at least 18 years of age\n2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome\n3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure\n\nExclusion Criteria:\n\n1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study\n2. Active bleeding\n3. Known hypersensitivity or contraindication to study medications\n4. Non-cardiac co-morbid conditions are present with life expectancy \\<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).\n5. Subjects with Cerebral hemorrhage history\n6. Subjects with stroke history in half a year\n7. subjects with malignant tumor\n8. subjects with whom oral anticoagulants are needed"}, 'identificationModule': {'nctId': 'NCT04255602', 'acronym': 'TIGER', 'briefTitle': 'A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Tong Ren Hospital'}, 'officialTitle': 'A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'HP2020125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dose ticagrelor', 'description': 'After treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a week,subjects will be treated with ticagrelor 60mg twice daily and aspirin 100mg once daily for until one year after drug eluting stent implantation', 'interventionNames': ['Drug: Ticagrelor 60mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard dose ticagrelor', 'description': 'subjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation', 'interventionNames': ['Drug: Ticagrelor 90mg']}], 'interventions': [{'name': 'Ticagrelor 60mg', 'type': 'DRUG', 'description': 'Ticagrelor 60mg plus Aspirin 100mg for experimental group', 'armGroupLabels': ['low dose ticagrelor']}, {'name': 'Ticagrelor 90mg', 'type': 'DRUG', 'description': 'Ticagrelor 90mg plus Aspirin 100mg for active comparator group', 'armGroupLabels': ['standard dose ticagrelor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529200', 'city': 'Taishan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yan Chen, Doctor', 'role': 'CONTACT'}, {'name': 'yan chen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Taishan people's hospital", 'geoPoint': {'lat': 22.25135, 'lon': 112.7799}}, {'city': 'Liaocheng', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhongwei Jia, doctor', 'role': 'CONTACT'}], 'facility': 'South East of Shandong hospital', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junbo Ge, Doctor', 'role': 'CONTACT'}, {'name': 'Junbo Ge, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'zhangshan hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200050', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Hou, Doctor', 'role': 'CONTACT'}, {'name': 'Lei Hou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caohui Qiu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yanan Peng, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'shanghai Tongren hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201100', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Hu, Doctor', 'role': 'CONTACT'}, {'name': 'Wei Hu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minhang hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Hou, Dr', 'role': 'CONTACT'}], 'facility': 'Songjiang hospital, Shanghai jiaotong university, school of medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Xiangshan', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianfei Ye, master', 'role': 'CONTACT'}], 'facility': 'Ningbo 4th hospital', 'geoPoint': {'lat': 30.23998, 'lon': 119.33315}}, {'city': 'Jining', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Yang', 'role': 'CONTACT'}], 'facility': 'Yanzhou branch of affiliated hospital of Jining medical university', 'geoPoint': {'lat': 35.405, 'lon': 116.58139}}], 'centralContacts': [{'name': 'Lei Hou, Doctor', 'role': 'CONTACT', 'email': 'Dr_houlei@163.com', 'phone': '13564868096'}, {'name': 'Junbo Ge, Doctor', 'role': 'CONTACT', 'email': 'Ge.junbo@zs-hospital.sh.cn'}], 'overallOfficials': [{'name': 'Junbo Ge, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}, {'name': 'Lei Hou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Tongren Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Tong Ren Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}