Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04611893
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring of NOAC Therapy: Standardizing Reference Intervals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood tests for haemoglobin level, platelet count, activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), creatinine clearance (by Cockcroft-Gault formula), alanine aminotransferase, alkaline phosphatase, bilirubin, modified thrombin time (dabigatran users), factor-Xa assay (for apixaban, rivaroxaban users) will be performed at the same time as blood taking for NOAC levels.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NOAC level in blood', 'timeFrame': 'One week after the recruitment', 'description': 'The NOAC level in blood before and after the medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'ischemic stroke'], 'conditions': ['Ischemic Stroke', 'Stroke, Acute', 'Stroke Syndrome', 'Ischemic']}, 'descriptionModule': {'briefSummary': 'This study is aimed to establish reference intervals of NOAC (dabigatran, apixaban and rivaroxaban) in ethnic Chinese patients.', 'detailedDescription': "360 patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited. After the informed consent, the patient will be needed for blood taking before and 2 hours after the medication (NOAC). The patient's demographic data and medical history will also be retreived from Central Medical Syetem too."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited from the Prince of Wales Hospital, either in-patient or out-patient clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ethnic Chinese ONLY\n2. 18 years old or above\n3. Non-valvular atrial fibrillation\n4. Duration of NOAC use at least 3 months\n5. No changes in NOAC dosage or type within 3 months\n6. Creatinine Clearance (by Cockcroft-Gault formula) \\>/=30mL/min\n\nExclusion Criteria:\n\n1. Valvular atrial fibrillation or no atrial fibrillation\n2. Recent haemorrhage or ischemia within 1 year\n3. Active liver disease\n4. Abnormal baseline clotting profile\n5. Abnormal baseline thrombocytopenia or thrombocytosis\n6. Thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein C, S, anti-thrombin III deficiency)\n7. Non-compliant patients, defined as missing any doses of NOAC in recent 1 month\n8. Anticoagulation for disorders other than AF\n9. Pregnancy'}, 'identificationModule': {'nctId': 'NCT04611893', 'briefTitle': 'Monitoring of NOAC Therapy: Standardizing Reference Intervals', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Monitoring of NOAC Therapy: Standardizing Reference Intervals', 'orgStudyIdInfo': {'id': 'Crec 2020.376'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ischemic stroke patient', 'description': 'Ischemic stroke patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited from the Prince of Wales Hospital, either in-patient or out-patient clinic'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Yiu Ming Bonaventure IP, MRCP', 'role': 'CONTACT', 'email': 'iym984@ha.org.hk', 'phone': '852-35053856'}], 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Yiu Ming Bonaventure IP, MRCP', 'role': 'CONTACT', 'email': 'iym984@ha.org.hk', 'phone': '852-35053856'}], 'overallOfficials': [{'name': 'Yiu Ming Bonaventure IP, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Resident', 'investigatorFullName': 'Dr. IP Yiu Ming Bonaventure', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}