Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT04240834
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
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': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-15', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac and cerebral events (MACCEs)', 'timeFrame': '12 months after randomization', 'description': 'Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization'}], 'secondaryOutcomes': [{'measure': 'Bleeding episode (Key secondary endpoint)', 'timeFrame': '12 months after randomization', 'description': 'Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)'}, {'measure': 'Platelet function', 'timeFrame': '12 months after randomization', 'description': 'Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)'}, {'measure': 'Medication adherence', 'timeFrame': '12 months after randomization'}, {'measure': 'Bleeding-related withdrawal', 'timeFrame': '12 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACS', 'PCI', 'DAPI', 'Aspirin', 'Ticagrelor'], 'conditions': ['Acute Coronary Syndrome', 'Interventional Cardiology']}, 'descriptionModule': {'briefSummary': 'The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.', 'detailedDescription': 'This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent\n* Able and willing to provide informed consent and participate in 12 months follow-up period\n* Able to receive DAPT treatment\n* Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria.\n\nClinical inclusion criteria:\n\n1. Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative \\<55 years old or in first-degree female relative \\<65 years old)\n2. Repeated myocardial infarction\n3. Positive serum cardiac troponin I/T\n4. Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)\n5. Type 2 diabetes mellitus under medication\n6. Chronic kidney disease (eGFR\\<60 mL/min/1.73 m2 or CrCl\\<60ml/min)\n\nAngiographic Inclusion Criteria:\n\n1. LM lesion requiring stents\n2. Proximal LAD lesion(s) requiring stents\n3. Bypass grafts lesion(s) requiring stents\n4. Overall stent length ≥60 mm\n5. History of in-stent thrombosis\n6. Bifurcation lesions requiring at least 2 stents\n7. Over two vessels lesions requiring stents\n8. Calcified target lesion(s) requiring atherectomy\n9. The intraoperative occurrence of no-reflow or slow-flow\n10. Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)\n\nExclusion Criteria:\n\n* Need for chronic oral anticoagulation\n* With cardiomyopathy（HCM/DCM/RCM）\n* With severe ventricular arrhythmia requiring ICD implantation\n* With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)\n* With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）\n* With hematological disorders（thrombocytopenia, severe anemia, leukaemia）\n* With severe liver disease or kidney failure\n* With malignant tumor\n* With cognitive impairment\n* Unable or unwilling to provide informed consent or undergo follow-up'}, 'identificationModule': {'nctId': 'NCT04240834', 'acronym': 'LD-ASPIRIN', 'briefTitle': 'Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Fu Wai Hospital, Beijing, China'}, 'officialTitle': 'Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2019XK320061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LD group', 'description': 'Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months', 'interventionNames': ['Drug: Aspirin', 'Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months', 'interventionNames': ['Drug: Aspirin', 'Drug: Ticagrelor']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Acetylsalicylic Acid'], 'description': 'Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)', 'armGroupLabels': ['Control group', 'LD group']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilinta/Brilique'], 'description': 'Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)', 'armGroupLabels': ['Control group', 'LD group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiyan Qian, MD, PhD', 'role': 'CONTACT', 'email': 'ahqhy712@163.com', 'phone': '+8613811386143'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Haiyan Qian, MD, PhD', 'role': 'CONTACT', 'email': 'ahqhy712@163.com', 'phone': '+8613811386143'}, {'name': 'Zhiyao Wei', 'role': 'CONTACT', 'email': 'weizhiyaoyx@163.com', 'phone': '+8615521192379'}], 'overallOfficials': [{'name': 'Haiyan Qian, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital, Beijing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Wai Hospital, Beijing, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Qian Haiyan', 'investigatorAffiliation': 'Fu Wai Hospital, Beijing, China'}}}}