Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT04684056
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1864}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of thromboembolic', 'timeFrame': 'Ninety days after catheter ablation', 'description': 'Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC'}, {'measure': 'Bleeding Incidence', 'timeFrame': 'Ninety days after catheter ablation', 'description': 'Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC'}], 'secondaryOutcomes': [{'measure': 'Death from any cause', 'timeFrame': 'Ninety days after catheter ablation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Direct oral anticoagulants', 'pharmacokinetics and pharmacodynamics', 'Atrial Fibrillation', 'Rivaroxaban', 'Dabigatran', 'Edoxaban', 'Anti-FXa assays', 'Dilute thrombin time', 'Liquid-chromatography tandem mass spectrometry'], 'conditions': ['Oral Anticoagulant', 'Atrial Fibrillation', 'Pharmacokinetics and Pharmacodynamics']}, 'descriptionModule': {'briefSummary': 'The incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with AF, but studies have shown that DOAC are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. However, the pharmacokinetic and pharmacodynamic of DOAC during the peri-operative period of CAAF were lacking in China. The purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of DOAC in patients with peri-operative atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Catheter ablation was performed under general anesthesia in patients with NVAF. Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran )were administered peri-operatively to prevent thrombotic events.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation\n* Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.\n\nExclusion Criteria:\n\n* Patients who have taken direct oral anticoagulants or warfarin before admission.\n* Cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing Rivaroxaban after surgery.\n* Abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity).\n* Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT04684056', 'acronym': 'LOAF', 'briefTitle': 'Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Asia Heart Hospital'}, 'officialTitle': 'Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants in Peri-operative Catheter Ablation for Patient With Atrial Fibrillation', 'orgStudyIdInfo': {'id': '2020-YXKY-B010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Riva-control group', 'description': 'Routine concentration of Rivaroxaban (Peak)'}, {'label': 'Riva-High group', 'description': 'High concentration of Rivaroxaban (Peak)'}, {'label': 'Riva-Low group', 'description': 'low concentration of Rivaroxaban (Peak)'}, {'label': 'Dabi-control group', 'description': 'Routine concentration of Dabigatran(Peak)'}, {'label': 'Dabi-High group', 'description': 'High concentration of Dabigatran(Peak)'}, {'label': 'Dabi-low group', 'description': 'low concentration of Dabigatran(Peak)'}, {'label': 'Edo-control group', 'description': 'Routine concentration of Edoxaban(Peak)'}, {'label': 'Edo-high group', 'description': 'High concentration of Edoxaban(Peak)'}, {'label': 'Edo-low group', 'description': 'low concentration of Edoxaban(Peak)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Qingkun Fan, M.D', 'role': 'CONTACT', 'email': 'fqk@wahh.com.cn', 'phone': '86+027-65796640'}, {'name': 'Litao Zhang, M.D', 'role': 'CONTACT', 'email': 'zhangleetau@163.com', 'phone': '86+027-65796640'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuhan Asia General Hospital (http://wagh.com.cn)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}