Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-02-01 @ 10:10 PM
Study NCT ID:
NCT02567461
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2015-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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': 'C552171', 'term': 'edoxaban'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombin-activated clot strength with or without edoxaban', 'timeFrame': '10 days', 'description': 'Comparison of thrombin-activated clot strength measured by TEG 6s system system between patients on DAPT plus high-dose edoxaban and patients on DAPT'}], 'secondaryOutcomes': [{'measure': 'Thrombin-activated clot strength with or without aspirin', 'timeFrame': '10 days', 'description': 'Comparison of thrombin-activated clot strength measured by TEG 6s system system between patients on DAPT plus high-dose edoxaban and patients on clopidogrel plus high-dose edoxaban'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dual antiplatelet therapy', 'clopidogrel', 'aspirin', 'edoxaban'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).', 'detailedDescription': 'Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor antagonist is pivotal for the treatment of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) and in patents following an acute coronary syndrome (ACS). Importantly, it is not uncommon that patients requiring DAPT also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, this treatment regimen has shown to be associated with an increased risk of bleeding, as well as ischemic complications. Over the past years, several non-vitamin K antagonist oral anticoagulants (NOACs), including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. In the phase III ENGAGE AF-TIMI 48 trial, edoxaban (60mg or 30mg once/daily) was non-inferior to warfarin with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and death from cardiovascular causes, in patients with AF. However, the effects of edoxaban in combination with DAPT in the setting of patients with CAD are unexplored. This may indeed represent a limitation for the uptake of edoxaban in modern day clinical practice where \\~10% of patients with AF also have CAD requiring PCI and thus may require triple antithrombotic therapy. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest as it has the potential reduce the risk of bleeding while preserving protection from ischemic events. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens (60mg or 30mg once/daily) in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients with angiographically documented CAD (previous PCI or ACS).\n2. On DAPT with low-dose aspirin (81mg od) and clopidogrel for at least 30 days as per standard-of-care.\n3. Age above 18.\n\nExclusion criteria:\n\n1. Active pathological bleeding, history of clinically significant bleeding events, or deemed at increased risk of bleeding.\n2. CrCL \\<15mL/min\n3. Any clinical indication to be on anticoagulant therapy\n4. Acute coronary events in the past 90 days\n5. Prior hemorrhagic stroke or intracranial hemorrhage\n6. Ischemic stroke/transient ischemic attack in the past 6 months\n7. Chronic use of nonsteroidal anti-inflammatory drugs\n8. On treatment with rifampin (induce or P-gp transporter)\n9. Known moderate or severe hepatic impairment (Child-Pugh B and C).\n10. On treatment with any antiplatelet agent other than aspirin and clopidogrel in the past 30 days.\n11. Platelet count \\<80x106/mL\n12. Hemoglobin \\<10g/dL\n13. Hemodynamic instability\n14. Pregnant females \\[women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study\\].'}, 'identificationModule': {'nctId': 'NCT02567461', 'acronym': 'EDOX-APT', 'briefTitle': 'Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Effects of Edoxaban on the Cellular and Protein Phase of Coagulation in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel (EDOX-APT): A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'IIS DSI001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAPT plus high-dose edoxaban', 'description': 'High-dose edoxaban will be represented by edoxaban 60mg od, which will be reduced to 30mg od in patients with ClCr ≤50mL/min.', 'interventionNames': ['Drug: Edoxaban 60 mg', 'Drug: Clopidogrel 75 mg', 'Drug: Aspirin 81 mg']}, {'type': 'EXPERIMENTAL', 'label': 'DAPT plus low-dose edoxaban', 'description': 'Low-dose edoxaban will be defined as edoxaban 30mg od, which will be reduced to 15mg od in patients with ClCr ≤50mL/min.', 'interventionNames': ['Drug: Edoxaban 30 mg', 'Drug: Clopidogrel 75 mg', 'Drug: Aspirin 81 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DAPT', 'description': 'Aspirin 81 mg od plus clopidogrel 75 mg od', 'interventionNames': ['Drug: Clopidogrel 75 mg', 'Drug: Aspirin 81 mg']}], 'interventions': [{'name': 'Edoxaban 60 mg', 'type': 'DRUG', 'otherNames': ['Savaysa'], 'description': 'Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.', 'armGroupLabels': ['DAPT plus high-dose edoxaban']}, {'name': 'Edoxaban 30 mg', 'type': 'DRUG', 'otherNames': ['Savaysa'], 'description': 'Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.', 'armGroupLabels': ['DAPT plus low-dose edoxaban']}, {'name': 'Clopidogrel 75 mg', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.', 'armGroupLabels': ['DAPT', 'DAPT plus high-dose edoxaban', 'DAPT plus low-dose edoxaban']}, {'name': 'Aspirin 81 mg', 'type': 'DRUG', 'otherNames': ['ASA'], 'description': 'Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.', 'armGroupLabels': ['DAPT', 'DAPT plus high-dose edoxaban', 'DAPT plus low-dose edoxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Dominick J Angiolillo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida College of Medicine-Jacksonville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}