Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-24 @ 12:50 PM
Study NCT ID:
NCT06144866
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluataion of NOAC Levels in Acute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'C522181', 'term': 'apixaban'}, {'id': 'C552171', 'term': 'edoxaban'}, {'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, buffycoat'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '3 months after stroke (ischemic or hemorrhagic)', 'description': 'Functional status measured by using the modified Rankin Scale.'}], 'secondaryOutcomes': [{'measure': 'Symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '24-36 hours after stroke', 'description': 'Type 2 parenchymal hemorrhage on the follow-up neuroimage in 24 to 36 hours after EVT, with neurological deterioration of ≥4 points on the National Institute of Health Stroke Scale (NIHSS) score from baseline'}, {'measure': 'Early neurological improvement', 'timeFrame': '24 hours after stroke', 'description': 'Reduction of 8 points or more in the NIHSS score within 24 hours.'}, {'measure': 'Successful reperfusion (in ischemic stroke patients receiving endovascular thrombectomy)', 'timeFrame': 'Evaluated after EVT', 'description': 'Defined as Thrombolysis in Cerebral Infarction (TICI) scale 2b to 3'}, {'measure': 'Recurrent ischemic stroke', 'timeFrame': '3 years', 'description': 'Neurological symptoms with ischemic lesion noted on neuroimaging'}, {'measure': 'Recurrent intracranial hemorrhage', 'timeFrame': '3 years', 'description': 'Neurological symptoms with hemorrhagic lesion noted on neuroimaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'Intracranial hemorrhage', 'Direct oral anticoagulant', 'Drug level'], 'conditions': ['Ischemic Stroke', 'Anticoagulant Adverse Reaction']}, 'descriptionModule': {'briefSummary': "Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended over warfarin in preventing stroke and thromboembolism among patients with atrial fibrillation (AF) in several guidelines. To evaluate the pharmacological effects of NOACs, directly measuring the concentration is the most arbitrary way since the correlation between concentration and common coagulation tests are not reliable. Our previous investigation reported under the fixed dose regimen, dabigatran exposure increased in elderly, renal impairments and patients with multiple co-morbid conditions. Our data also showed difference in NOACs exposure in Asians. For example, patients under rivaroxaban, in comparison to apxiaban, were more likely to have lower than expected range drug level. Furthermore, the NOACs concentration also affected by the prescription pattern of physicians (non-compliant to labeled dose) and patients' behavior (poor medication adherence).\n\nThe relationship between NOACs exposure and safety has been elucidated in large-scale clinical trials. As the NOACs level increased, the risk for bleeding increased, too. Nevertheless, no additional protection was noted with increased NOACs levels. In post marketing surveillance, bleeding and thrombotic events have been reported. Investigating the NOACs level among these patients helps evaluating the residual drug in the body, which could be a reference for clinical decision in emergent situation.\n\nSpecific purpose: Investigate the correlation between NOACs concentration upon the arrival of emergency department (ED) and important clinical outcomes including systemic thromboembolism, and major bleeding.\n\nDirection for investigation:\n\n1. Prospectively record the NOACs concentration among AF patients under NOACs therapy and suffered from ischemic stroke (IS), transient ischemic attack (TIA), intracerebral hemorrhage (ICH) and other major bleeding.\n2. Investigate the correlation between NOACs concentration upon ED arrival and thromboembolic or bleeding events.\n3. Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.", 'detailedDescription': "Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended over warfarin in preventing stroke and thromboembolism among patients with atrial fibrillation (AF) in several guidelines. To evaluate the pharmacological effects of NOACs, directly measuring the concentration is the most arbitrary way since the correlation between concentration and common coagulation tests are not reliable. Our previous investigation reported under the fixed dose regimen, dabigatran exposure increased in elderly, renal impairments and patients with multiple co-morbid conditions. Our data also showed difference in NOACs exposure in Asians. For example, patients under rivaroxaban, in comparison to apxiaban, were more likely to have lower than expected range drug level. Furthermore, the NOACs concentration also affected by the prescription pattern of physicians (non-compliant to labeled dose) and patients' behavior (poor medication adherence).\n\nThe relationship between NOACs exposure and safety has been elucidated in large-scale clinical trials. As the NOACs level increased, the risk for bleeding increased, too. Nevertheless, no additional protection was noted with increased NOACs levels. In post marketing surveillance, bleeding and thrombotic events have been reported. Investigating the NOACs level among these patients helps evaluating the residual drug in the body, which could be a reference for clinical decision in emergent situation.\n\nSpecific purpose:\n\n1. Prospectively record the NOACs concentration among AF patients under NOACs therapy and suffered from IS, TIA, ICH or major bleeding.\n\n AF patients who presented to emergent department (ED) for acute IS, TIA, ICH (non-traumatic), or other major bleeding and was under NOACs therapy will be recruited to this study. Blood sample will be collected before acute management to measure NOACs concentration. Co-morbid disease, laboratory tests and concurrent medications will be retrieved from electronic medical records. The onset, location, severity of IS. ICH or other major bleeding, and the outcome and long-term managements will be prospectively recorded.\n2. Investigate the correlation between NOACs concentration and thromboembolic or bleeding events.\n\n For each NOACs, we are going to compare the differences in NOACs exposure between patients with thromboembolism or major bleedi. Important baseline characteristics, co-medications and disease severity will be adjusted before making comparison.\n3. Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.\n\nFrom the data of NOACs concentration among patients with IS or ICH, we plan to propose a therapeutic range with acceptable efficacy and safety for NOACs therapy. Our data will provide a guide for physicians to make important clinical decision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient under direct oral anticoagulant therapy and suffered from ischemic stroke or intracranial hemorrhage.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 20 years\n2. Having AF diagnosis\n3. Under NOACs therapy including dabigatran, rivaroxaban, apixaban and edoxaban.\n4. Admitted for acute IS, transient ischemic attack (TIA), ICH or major bleeding\n\nExclusion Criteria:\n\n1. The ICH is resulted from trauma.\n2. Decline the inform consent.'}, 'identificationModule': {'nctId': 'NCT06144866', 'briefTitle': 'Evaluataion of NOAC Levels in Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants Concentration Among Patients With Acute Stroke (The Direct Oral AntiCoagulant Registry in Taiwan-Emergent Department, DOACT-ED)', 'orgStudyIdInfo': {'id': '202003059RINA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dabigatran, rivaroxaban, apixaban, edoxaban', 'type': 'DRUG', 'otherNames': ['Direct oral anticoagulants'], 'description': 'For patients who received direct oral anticoagulants (DOAC) before ischemic stroke or intracranial hemorrhage, the DOAC level upon hospital arrival will be measured.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shin Yi Lin, MS', 'role': 'CONTACT', 'email': 'hsin924@ntuh.gov.tw', 'phone': '+886972651956'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shin Yi Lin, M.S.', 'role': 'CONTACT', 'email': 'hsin924@ntuh.gov.tw', 'phone': '+88623123456', 'phoneExt': '63699'}], 'overallOfficials': [{'name': 'Shin Yi Lin, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'National Taiwan University Clinical Trial Center', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}