Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-17 @ 7:14 PM
Study NCT ID:
NCT02809469
Status:
UNKNOWN
Last Update Posted:
2016-06-22
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apixaban Dose Reduction in Patients With Elevated Drug Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-06-25', 'releaseDate': '2021-05-27'}, {'resetDate': '2021-08-20', 'releaseDate': '2021-08-19'}], 'estimatedResultsFirstSubmitDate': '2021-05-27'}}, '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who achieve target range', 'timeFrame': '1 week after dose reduction', 'description': 'Patients who undergo dose reduction will have their apixaban drug level measured one week later. The proportion who develop levels between 50-170ng/mL after dose reduction will be determined.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with persistently elevated levels', 'timeFrame': '2 weeks after initial blood work', 'description': 'Patients meeting inclusion criteria will have apixaban drug levels measured. Those with levels above 170ng/mL will have levels repeated 2 weeks later. The proportion of eligible patients with levels above 170ng/mL on both occasions will be determined.'}, {'measure': 'Proportion of patients who spontaneously develop levels below the median of the observed on-therapy range', 'timeFrame': '2 weeks after initial blood work', 'description': 'Patients meeting inclusion criteria will have apixaban drug levels measured. Those with levels above 170ng/mL will have levels repeated 2 weeks later. The proportion of patients with levels above 170ng/mL on the first measurement who spontaneously develop levels below 122ng/mL on the second measurement will be determined.'}, {'measure': 'Proportion of patients who develop low levels after dose reduction', 'timeFrame': '1 week after dose reduction', 'description': 'Patients who undergo dose reduction will have apixaban drug levels measured 7-10 days after dose reduction. The proportion of patients with drug levels below 50ng/mL after dose reduction will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious and safe for the overall AF population; however, patients older than age 85, with creatinine clearance \\<40mL/min, or who weighed \\<50kg were poorly represented in these trials, yet they are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and low body weight are all associated with elevated drug levels, and elevated drug levels are associated with an increased risk of bleeding. Therefore, clinicians are concerned about the risk of bleeding and are unsure of how best to treat this patient population. Although other anticoagulants are available, apixaban is attractive because it has a low rate of bleeding, low dependence on the kidneys for clearance, and does not require frequent ongoing monitoring and dose adjustment. This study will include patients taking apixaban who were not well-represented in phase III trials - those with age \\>85, creatinine clearance \\<40mL/min, or weight \\<50kg - who are also at increased risk of having elevated drug levels due to these clinical characteristics. Participants will have apixaban levels measured, and those with persistently elevated levels will have their dose reduced. Drug levels will be measured again after dose reduction to determine if the levels are reduced without becoming dangerously low.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-valvular atrial fibrillation (permanent, paroxysmal, or persistent) receiving apixaban with any of the following characteristics: age\\>85; creatinine clearance \\<40mL/min; or body weight \\<50kg.\n\nExclusion Criteria:\n\n* Inability to visit Hamilton General Hospital;\n* Inability or unwillingness to provide written informed consent.\n* Stroke or thromboembolic event in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT02809469', 'acronym': 'ADREL', 'briefTitle': 'Apixaban Dose Reduction in Patients With Elevated Drug Levels', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Optimal Dosing of Apixaban in Patients at Risk of Elevated Drug Levels: A Study Evaluating a Strategy of Apixaban Drug Level Measurement and Dose Reduction in Patients With Atrial Fibrillation Who Are at Risk of Elevated Drug Levels', 'orgStudyIdInfo': {'id': 'ADREL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose reduction', 'description': 'Eligible patients with apixaban levels persistently above 170ng/mL on two occasions, 2 weeks apart, will undergo apixaban dose reduction.', 'interventionNames': ['Drug: apixaban dose reduction']}], 'interventions': [{'name': 'apixaban dose reduction', 'type': 'DRUG', 'otherNames': ['Eliquis dose reduction'], 'description': 'Participants taking apixaban 5mg BID will have their dose reduced to 2.5mg BID, and those taking 2.5mg BID will have their dose reduced to 2.5mg once daily (in the morning).', 'armGroupLabels': ['Dose reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Vinai C. Bhagirath, MD MSc.', 'role': 'CONTACT', 'email': 'bhagiv@mcmaster.ca', 'phone': '905 527 1710', 'phoneExt': '1'}, {'name': 'John Eikelboom, MBBS MSc.', 'role': 'CONTACT', 'email': 'eikelbj@mcmaster.ca', 'phone': '905 527 4322', 'phoneExt': '40323'}], 'overallOfficials': [{'name': 'Vinai C. Bhagirath, MD MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-05-27', 'type': 'RELEASE'}, {'date': '2021-06-25', 'type': 'RESET'}, {'date': '2021-08-19', 'type': 'RELEASE'}, {'date': '2021-08-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hamilton Health Sciences Corporation'}}}}