Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-29 @ 11:34 AM
Study NCT ID:
NCT06103266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D003324', 'term': 'Coronary Artery 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': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-10-22', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary ischemic endpoint', 'timeFrame': '6 months', 'description': 'Composite of all-cause death, myocardial infarction, Academic Research Consortium defined definite stent trhombosis, or ischemic stroke'}, {'measure': 'Primary bleeding endpoint', 'timeFrame': '6 months', 'description': 'International Society on Thrombosis and Haemostasis defined major bleeding or clinically relevant non-major bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Rationale: Patients with atrial fibrillation who undergo percutaneous coronary intervention for coronary artery disease are treated with antiplatelet therapy on top of a non-vitamin K oral anticoagulant. Inevitably, this is associated with a higher risk of (major) bleeding. Given the reduction of ischemic risk with low-dose rivaroxaban and advances in stent properties, implantation techniques, and post-PCI management, it may be possible to treat atrial fibrillation patients after percutaneous coronary intervention with full-dose rivaroxaban and without antiplatelet therapy.\n\nObjective: This study will serve as a pilot to investigate the feasibility and safety of rivaroxaban monotherapy in 50 patients with atrial fibrillation after percutaneous coronary intervention.\n\nStudy design: Single-centre, single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis Study population: Patients with atrial fibrillation and an indication for a non-vitamin K oral anticoagulant who undergo optimal percutaneous coronary intervention Intervention: Rivaroxaban 20 mg once daily or 15 mg once daily, in case of moderate-to-severe kidney dysfunction, for 6 or 12 months without antiplatelet therapy Main study endpoint: The primary ischemic endpoint is the composite of all-cause death, myocardial infarction, definite stent thrombosis, and ischemic stroke at 6 months after percutaneous coronary intervention. The primary bleeding endpoint is the composite of International Society on Thrombosis and Haemostasis defined major and clinically relevant non-major bleeding at 6 months after percutaneous coronary intevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Successful PCI\n* History of or newly diagnosed (\\<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC\n* Treatment with a loading dose of clopidogrel and aspirin prior to or during PCI\n\nExclusion Criteria:\n\n* Known allergy or contraindication for rivaroxaban\n* Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)\n* Overwriting indication for DAPT (e.g. TIA/CVA or PAD)\n* Mechanical heart valve prosthesis\n* Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)\n* Intracardiac thrombus or apical aneurysm requiring OAC\n* Kidney failure (eGFR \\<15)\n* Active liver disease (ALT, ASP, AP \\>3x ULN or active hepatitis A, B or C)\n* Active malignancy excluding non-melanoma skin cancer\n* Active bleeding on randomization\n* Severe anaemia requiring blood transfusion\n* Pregnancy or breast-feeding women\n* Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS\n* PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions\n* Participation in another trial with an investigational drug or device (i.e. stent)'}, 'identificationModule': {'nctId': 'NCT06103266', 'acronym': 'IMPACT AF-PCI', 'briefTitle': 'Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention'}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivaroxaban monotherapy', 'description': 'Once daily rivaroxaban 20 mg or 15 mg with reduced kidney function (eGFR 15 - 49 mmol/L) for 6 months in case of percutaneous coronary intervention for stable coronary artery disease or 12 months in case of percutaneous coronary intervention for acute coronary syndrome without concurrent antiplatelet therapy', 'interventionNames': ['Drug: Rivaroxaban']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Once daily rivaroxaban 20 mg or 15 mg with reduced kidney function (eGFR 15 - 49 mmol/L) for 6 months in case of percutaneous coronary intervention for stable coronary artery disease or 12 months in case of percutaneous coronary intervention for acute coronary syndrome without concurrent antiplatelet therapy', 'armGroupLabels': ['Rivaroxaban monotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'I. Tarik Küçük, MD', 'role': 'CONTACT', 'email': 'i.t.kucuk@amsterdamumc.nl', 'phone': '020 56 66405', 'phoneExt': '+31'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'J.P.S Henriques', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor doctor', 'investigatorFullName': 'J.P.S Henriques', 'investigatorAffiliation': 'Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)'}}}}