Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-05 @ 2:19 AM
Study NCT ID:
NCT03150303
Status:
TERMINATED
Last Update Posted:
2020-08-19
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 532}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of budget', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence rate of bleeding or thromboembolic events during the peri-procedural period', 'timeFrame': 'Each patient will be followed for 30 days', 'description': 'the occurrence rate of bleeding or thromboembolic events during the peri-procedural period defined as the period between 5 days before surgery plus 30 days after the invasive procedure (if no anticoagulant interruption) or 30 days after the resumption of oral anticoagulant (in case of an anticoagulant interruption).'}], 'secondaryOutcomes': [{'measure': 'risk factors for bleeding in the peri-procedural period', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To identify risk factors for bleeding in the peri-procedural period'}, {'measure': 'risk factors for thromboembolic events in the peri-procedural period', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To identify risk factors for thromboembolic events in the peri-procedural period'}, {'measure': 'peri-procedural management of each treatment (VKA, and each DOAC)', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To describe the peri-procedural management of each treatment (VKA, and each DOAC)'}, {'measure': 'prescribers involved in the possible change of anticoagulant prescription prior the oral surgery', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery'}, {'measure': 'risk of bleeding on DOAC and on VKA', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To compare the risk of bleeding on DOAC and on VKA'}, {'measure': 'risk of thromboembolic complications on DOAC and on VKA', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To compare the risk of thromboembolic complications on DOAC and on VKA'}, {'measure': 'net clinical benefit of DOAC compared to VKA treatment', 'timeFrame': 'Each patient will be followed for 30 days.', 'description': 'To evaluate the net clinical benefit of DOAC compared to VKA treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periprocedural period', 'Anticoagulant treatment', 'Thromboembolic events', 'Bleeding events'], 'conditions': ['Oral Anticoagulants', 'Invasive Procedure']}, 'referencesModule': {'references': [{'pmid': '30887189', 'type': 'DERIVED', 'citation': 'Radoi L, Hajage D, Giboin C, Maman L, Monnet-Corti V, Descroix V, Mahe I. Perioperative management of oral anticoagulated patients undergoing an oral, implant, or periodontal procedure: a survey of practices of members of two dental scientific societies, the PRADICO study. Clin Oral Investig. 2019 Dec;23(12):4311-4323. doi: 10.1007/s00784-019-02877-1. Epub 2019 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study.\n\nThe main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure).\n\n0\\. The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.', 'detailedDescription': "Manager Centre de Pharmaco-épidémiologie de l'AP-HP\n\nTitle Survey about oral anticoagulant peri-procedural management in patients undergoing an oral surgery, implantology or periodontology\n\nAcronym PRADICO\n\nInvestigator Coordinator Isabelle MAHE\n\nNumber of investigational sites 100\n\nNumber of patients 2000\n\nPopulation Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology\n\nResearch calendar Duration of inclusions: 1 year Duration of follow up: 30 days Study duration: 13 months\n\nSelection criteria\n\nInclusion criteria :\n\nPatients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO (Société Française de Chirurgie Orale) or a periodontologist member of the SFPIO (Société Française de Parodontologie et d'Implantologie Orale) taking part to the study.\n\nEach investigator will include 10 patients treated with long-term DOAC, and 10 consecutive patients treated with long-term VKA. For the DOAC group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban).\n\nNon-inclusion criteria :\n\nPatients receiving both VKA and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents\n\nObjectives\n\nPrimary aim:\n\nTo assess the composite rate of thromboembolic and bleeding events occurring within the peri-procedural period, in patients on long-term DOAC and VKA and undergoing an oral surgery, implantology or periodontology.\n\nSecondary aims :\n\n* To identify risk factors for bleeding during the peri-procedural period\n* To identify risk factors for thromboembolic events during the peri-procedural period\n* To describe the peri-procedural management of each treatment (VKA or DOAC)\n* To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery\n* To compare the risk of bleeding on DOAC and on VKA\n* To compare the risk of thromboembolic complications on DOAC and on VKA\n* To evaluate the net clinical benefit of DOAC compared to VKA treatment\n\nEndpoints\n\nPrimary endpoint :\n\nA composite outcome: the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period.\n\nSecondary endpoints :\n\n* Incidence of bleeding events\n* incidence of thromboembolic events\n* net clinical benefit of DOAC compared to VKA\n\nMethodology Prospective observational non interventional multicentric cohort study in adult population under long-term anticoagulant treatment (DOAC or VKA) and undergoing an oral, periodontal or implant surgery, by liberal practitioners or oral specialists at hospital.\n\nStatistical analysis The occurrence rate of hemorrhagic or thromboembolic events during peri-procedural period will be calculated globally and in each group (VKA or DOAC) as a percentage with 95% CI.\n\nFinancements Company's grant\n\n* BMS\n* DAIICHI SANKYO"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO taking part to the study.\n\nEach investigator will include 10 patients treated with long-term direct oral anticoagulants, and 10 consecutive patients treated with long-term Vitamin K Antagonists. For the oral anticoagulants group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban).\n\nExclusion Criteria:\n\n* Patients receiving both Vitamin K Antagonists and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents'}, 'identificationModule': {'nctId': 'NCT03150303', 'acronym': 'PRADICO', 'briefTitle': 'Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology', 'orgStudyIdInfo': {'id': 'HAO-16007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vitamin K Antagonists (VKA)', 'description': 'Patients on VKA'}, {'label': 'Direct Oral Anticoagulant (DOAC)', 'description': 'Patients on OAD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Isabelle Mahé, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}