Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT05646394
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D010975', 'term': 'Platelet Aggregation Inhibitors'}], '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'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with thromboembolism verified by diagnostic imaging, electrocardiogram or troponin rise', 'timeFrame': '2 years', 'description': 'Composite of arterial thrombosis (stroke, myocardial infarction, peripheral arterial thrombosis or embolism), venous thromboembolism (thrombosis in any deep vein or pulmonary embolism), and vascular death.'}, {'measure': 'Number of Participants with major hemorrhage fulfilling at least one of the International Society on Thrombosis and Haemostasis criteria', 'timeFrame': '2 years', 'description': 'Major hemorrhage according to the International Society on Thrombosis and Haemostasis'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with arterial thrombosis verified by diagnostic imaging', 'timeFrame': '2 years', 'description': 'stroke, myocardial infarction, peripheral arterial thrombosis or embolism'}, {'measure': 'Number of Participants with venous thromboembolism verified by diagnostic imaging', 'timeFrame': '2 years', 'description': 'thrombosis in any deep vein or pulmonary embolism'}, {'measure': 'Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise', 'timeFrame': '2 years', 'description': 'Death due to arterial or venous thromboembolism'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anticoagulation', 'vitamin K antagonist', 'antiaggregant', 'stroke', 'myocardial infarction', 'hemorrhage'], 'conditions': ['Antiphospholipid Syndrome', 'Arterial Thrombosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://redcap.isth.org/surveys/?s=9RC8EEDPX3', 'label': 'Case report form - DO NOT ENTER DATA WITHOUT OBTAINING CENTER NUMBER; links to study protocol, ethics approval; informed consent form'}]}, 'descriptionModule': {'briefSummary': 'The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either A) a VKA with therapeutic range, INR 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0, C) a VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen. The follow-up is 2 years.', 'detailedDescription': 'The optimal antithrombotic management of patients with antiphospholipid syndrome and arterial thrombotic events is unclear. The guidelines provide several options, mostly with vitamin K antagonist with/without an antiplatelet agent. Dual antiplatelet therapy (DAPT) was in a meta-analysis potentially effective, but included studies were few and small.\n\nThe primary aim is to compare a vitamin K antagonist (VKA), i.e. warfarin, acenocoumarol, phenprocoumon etc, with international normalized ratio 2.0-3.0 plus low-dose aspirin (75-100 mg) with DAPT - typically low-dose aspirin plus clopidogrel (75 mg daily) but other combinations will be acceptable. The registry will also include patients treated with VKA alone at standard- or high-intensity, since this is recommended and will serve as reference groups in comparison with VKA + low-dose aspirin and versus DAPT. The outcomes are (efficacy) arterial or venous thromboembolism, vascular death or (safety) major bleeding.\n\nA secondary objective is to analyze how the cardiovascular risk factors (hypertension, hyperlipidemia, obesity, smoking, diabetes, and heart failure), venous thrombotic risk factors (previous venous thromboembolism, cancer, immobility, chronic inflammatory disease) and anti-phospholipid profile contribute to recurrent arterial thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The decision on the treatment regimen should have been made by the treating physician on clinical grounds and judgement, prior to informing the patients about the registry. The information should include that vitamin K antagonist is the recommended standard, either alone or in combination and, in case dual antiplatelet regimen is chosen, an explanation to the patient for what reasons it should be used or continued. Patients that have been started on either of the eligible regimens after the most recent arterial thromboembolic event and within the past 12 months can be approached and informed about the study. If the patient meets the inclusion criteria and does not have any of the exclusion criteria, the investigator or designated representative obtains consent for collection of data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of at least 18 years of age with confirmed antiphospholipid syndrome according to Sydney criteria and with first or recurrent arterial thrombotic manifestation, including those with asymptomatic brain infarcts on diagnostic imaging.\n2. Treatment with either A) a vitamin K antagonist (VKA) with therapeutic range, international normalized ratio (INR) 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0 or C) VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen, if considered appropriate by the treating physician.\n3. Signed informed consent obtained (in jurisdictions where required).\n\nExclusion Criteria:\n\n1. Inability to follow the patient due to geographical or other reasons.\n2. Patients with documented poor compliance.\n3. Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.\n4. Pregnancy or planned pregnancy.\n5. Venous thrombotic event diagnosed after the last arterial event.'}, 'identificationModule': {'nctId': 'NCT05646394', 'briefTitle': 'Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS', 'orgStudyIdInfo': {'id': 'AATAAPS2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dual antiplatelet therapy', 'type': 'DRUG', 'otherNames': ['Aspirin', 'Plavix', 'Brilinta', 'Effient'], 'description': 'Aspirin plus any of clopidogrel, ticagrelor or prasugrel'}, {'name': 'Combined antithrombotic therapy', 'type': 'DRUG', 'otherNames': ['Vitamin K antagonist plus aspirin', 'Vitamin K antagonist plus antiaggregant', 'Vitamin K antagonist plus antiplatelet agent'], 'description': 'Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.'}, {'name': 'Vitamin K antagonist standard intensity', 'type': 'DRUG', 'otherNames': ['VKA'], 'description': 'vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0'}, {'name': 'Vitamin K antagonist high intensity', 'type': 'DRUG', 'otherNames': ['VKA'], 'description': 'vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1113 AAJ', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Patricia Casais, MD, PhD', 'role': 'CONTACT', 'email': 'patricia.casais@odontologia.uba.ar', 'phone': '(11)50324141'}], 'facility': 'Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Soledad Molnar, MD', 'role': 'CONTACT', 'phone': '0351-4142121'}], 'facility': 'Clinica Universitaria Reina Fabiola', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'L9H 7M1', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sam Schulman', 'role': 'CONTACT', 'email': 'schulms@mcmaster.ca', 'phone': '9059796437'}], 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Sam Schulman, MD, PhD', 'role': 'CONTACT', 'email': 'schulms@mcmaster.ca', 'phone': '+19055270271', 'phoneExt': '44810'}, {'name': 'Hannah Cohen, MD, FRCP', 'role': 'CONTACT', 'email': 'hannah.cohen@ucl.ac.uk', 'phone': '+442034477368', 'phoneExt': '9456'}], 'overallOfficials': [{'name': 'Cary Clark', 'role': 'STUDY_DIRECTOR', 'affiliation': 'International Society on Thrombosis and Haemostasis'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Study protocol and ICF are available now and for 10 years after the end of the study. IPD will be available after the primary data have been published and for 10 years', 'ipdSharing': 'YES', 'description': 'The study protocol and ICF are available on the ISTH website (under SSC - RedCap. IPD will be shared after the primary publication.', 'accessCriteria': 'A research plan is required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Society on Thrombosis and Haemostasis', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}