Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02998905
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2016-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], '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'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2016-11-25', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weighted net clinical benefit', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Weighted net clinical benefit factoring the impact of ischemic stroke, intracerebral hemorrhage, non-intracerebral intracranial hemorrhage, major extracranial hemorrhage and myocardial infarction on death and disability.'}], 'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Through study completion; ~ 30 months', 'description': 'The mean number of patients randomized per site per year.'}, {'measure': 'Composite of ischemic stroke and recurrent intracerebral hemorrhage', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'The composite of ischemic stroke and recurrent intracerebral hemorrhage'}], 'secondaryOutcomes': [{'measure': 'Refusal rate', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Average number of eligible patients per site who refuse consent.'}, {'measure': 'Retention rate', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Randomized patients who completed 6 months of follow-up on drug or died during trial participation.'}, {'measure': 'Ischemic stroke', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute ischemic stroke.'}, {'measure': 'Intracerebral hemorrhage', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'A neurologic deficit associated with an intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy.'}, {'measure': 'Fatal stroke', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Death that is attributable to an ischemic stroke or intracerebral hemorrhage.'}, {'measure': 'Myocardial infarction', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Defined by presence of at least one of the following a compatible clinical history and characteristic serum enzymes changes with or without electrocardiographic abnormalities; clinical history and serial ST-segment and T-wave changes which are specifically located with respect to the electrocardiographic leads accompanied by elevation of CPK-MB isoenzyme or troponin in serum; the development of large Q-waves on electrocardiography associated with changes in the ST-segments and T-waves in specific and appropriate leads which indicate the location of the infarct, even in the absence of symptoms or abnormalities in serum enzymes; development of discrete, segmental left ventricular systolic wall motion abnormality concurrent with compatible clinical history, electrocardiographic changes or serum enzyme abnormalities; or histopathological evidence of subacute myocardial necrosis.'}, {'measure': 'All-cause mortality', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Persistent and irreversible absence of brain or brainstem function.'}, {'measure': 'Systemic thromboembolism', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Emboli to the arterial circulation excluding myocardial infarction, ischemic stroke or intracerebral hemorrhage.'}, {'measure': 'Major hemorrhage', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Bleeding accompanied by one or more of the following - a decrease in the hemoglobin level of ≥20 g per liter over a 24-hour period, transfusion of ≥2 units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding.'}, {'measure': 'Intracranial hemorrhage', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Signs or symptoms associated with an epidural, subdural, subarachnoid, intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy.'}, {'measure': 'Composite of all stroke, myocardial infarct, systemic thromboembolism or death', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Composite of all stroke, myocardial infarct, systemic thromboembolism or death'}, {'measure': 'Modified Rankin Scale (mRS)', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Average mRS score'}, {'measure': 'Montreal Cognitive Assessment (MOCA)', 'timeFrame': 'Through study completion; average of 1 year', 'description': 'Average MOCA score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '36700520', 'type': 'DERIVED', 'citation': 'Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.'}]}, 'descriptionModule': {'briefSummary': 'To determine the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.', 'detailedDescription': 'The NASPAF-ICH study is an open-label, randomized, controlled, phase II study that will assess the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with acetylsalicylic acid (ASA) for stroke prevention in patients with high-risk atrial fibrillation and previous intracerebral hemorrhage, as well as provide evidence of efficacy and safety for planning of a phase III trial. Recruitment will occur at 10 high-volume stroke research centres across Canada over 2 years, at which 100 adult patients with high-risk atrial fibrillation (CHADS2 ≥2) and previous spontaneous or traumatic ICH (intraparenchymal or intraventricular hemorrhage while on or off anticoagulation) will be randomly assigned to receive a NOAC (particular agent at the discretion of the local investigator) or ASA 81 mg per day. Patients will be followed for a mean of 1 year to a common end-study date. The feasibility of recruitment will also be tested. The investigators estimate that five patients per year per centre can be recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous primary intracerebral hemorrhage\n* Atrial fibrillation (CHADS2 ≥ 2)\n\nExclusion Criteria:\n\n* Non-stroke indication for antiplatelet or anticoagulant therapy\n* Recent intracerebral hemorrhage within 14 days\n* Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis\n* Prior symptomatic lobar intracerebral hemorrhage other than the qualifying event\n* Uncontrollable hypertension consistently above SBP/DBP of 160/100 mmHg\n* Known hypersensitivity to either ASA or NOACs\n* Inability to adhere to study procedures'}, 'identificationModule': {'nctId': 'NCT02998905', 'acronym': 'NASPAF-ICH', 'briefTitle': 'NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study', 'orgStudyIdInfo': {'id': 'NASPAF-ICH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NOAC', 'description': 'Apixaban or dabigatran or edoxaban or rivaroxaban', 'interventionNames': ['Drug: NOAC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetylsalicylic Acid', 'description': 'Acetylsalicylic acid', 'interventionNames': ['Drug: Acetylsalicylic Acid']}], 'interventions': [{'name': 'NOAC', 'type': 'DRUG', 'description': 'Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation. The particular agent is at the discretion of the local investigator.', 'armGroupLabels': ['NOAC']}, {'name': 'Acetylsalicylic Acid', 'type': 'DRUG', 'description': 'Acetylsalicylic acid 81 mg/day', 'armGroupLabels': ['Acetylsalicylic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Coastal Health Research Institute', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L9G1J8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre - University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Notre-Dame du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Ashkan Shoamanesh, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine (Neurology)', 'investigatorFullName': 'Ashkan Shoamanesh', 'investigatorAffiliation': 'Population Health Research Institute'}}}}