Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-29 @ 11:23 PM
Study NCT ID:
NCT05638867
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2022-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], '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': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, Two-arm, Randomized Superiority Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3944}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-14', 'studyFirstSubmitDate': '2022-11-26', 'studyFirstSubmitQcDate': '2022-12-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bleeding', 'timeFrame': '12 months', 'description': 'BARC 3,5 bleeding events'}], 'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)', 'timeFrame': '12 months', 'description': 'Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism'}], 'secondaryOutcomes': [{'measure': 'All-cause Death', 'timeFrame': '12 months'}, {'measure': 'Cardiac Death', 'timeFrame': '12 months'}, {'measure': 'Myocardial Infarction', 'timeFrame': '12 months'}, {'measure': 'Stroke', 'timeFrame': '12 months'}, {'measure': 'Ischemia-driven Revascularization', 'timeFrame': '12 months'}, {'measure': 'Stent Thrombosis', 'timeFrame': '12 months'}, {'measure': 'Systemic Embolism', 'timeFrame': '12 months'}, {'measure': 'Net Adverse Clinical Events', 'timeFrame': '12 months', 'description': 'Composite events including MACCE and bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Novel Oral Anticoagulant', 'PARIS risk score', 'D-dimer', 'Acute Coronary Syndrome', 'Percutaneous Coronary Intervention'], 'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '40379336', 'type': 'DERIVED', 'citation': 'Jia S, Song Y, Yuan D, Wang P, Xu J, Chen Y, Zhang C, Zhao X, Yuan JQ. PARIS coronary thrombosis risk score combined with D-dimer to guide new oral anticoagulant antithrombotic therapy in patients with acute coronary syndrome after percutaneous coronary intervention: study protocol for the PRIDE-ACS trial. BMJ Open. 2025 May 15;15(5):e090126. doi: 10.1136/bmjopen-2024-090126.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare short-term Triple Antithrombotic Therapy (DAPT + Rivaroxaban) followed by DAPT with standard DAPT in selected ACS patients with high ischemic risk. The main questions it aims to answer are:\n\n* Whether the intervention is effective in reducing ischemic events\n* Whether the intervention is safe from increasing bleeding events, especially severe or fatal ones\n\nParticipants will be randomized to receive standard DAPT therapy for the entire study duration or low-dose rivaroxaban+DAPT for 3 months, followed by standard DAPT for the rest of the study duration. Patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,\n* Aged 18-65 years old,\n* Elevated D-dimer levels (≥0.28 μg/ml) on admission or PARIS coronary thrombosis risk score ≥ 3 points,\n* Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,\n* Indicated for dual antiplatelet medication\n\nExclusion Criteria:\n\n* Platelet level below 90 x10\\^6\n* Hemoglobin level is less than 11g/dL\n* History of severe bleeding\n* History of stroke/TIA\n* Severe hepatic/renal insufficiency\n* Indicated for anticoagulation'}, 'identificationModule': {'nctId': 'NCT05638867', 'briefTitle': 'NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'NCRC2022003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)', 'interventionNames': ['Drug: Aspirin + Clopidogrel + Rivaroxaban']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)', 'interventionNames': ['Drug: Aspirin + Clopidogrel']}], 'interventions': [{'name': 'Aspirin + Clopidogrel + Rivaroxaban', 'type': 'DRUG', 'otherNames': ['Triple Antithrombotic Therapy'], 'description': 'Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily', 'armGroupLabels': ['Experimental Group']}, {'name': 'Aspirin + Clopidogrel', 'type': 'DRUG', 'otherNames': ['Dual Antiplatelet Therapy'], 'description': 'Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinqing Yuan, MD', 'role': 'CONTACT', 'email': 'dr_jinqingyuan@sina.com', 'phone': '+86-10-68314466'}], 'facility': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jinqing Yuan, MD', 'role': 'CONTACT', 'email': 'dr_jinqingyuan@sina.com', 'phone': '+86-10-68314466'}], 'overallOfficials': [{'name': 'Jinqing Yuan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Coronary Heart Disease Center, Director of Ward 1', 'investigatorFullName': 'Jinqing Yuan', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}