Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-22 @ 5:00 AM
Study NCT ID:
NCT03636295
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2018-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low INR to Minimize Bleeding With Mechanical Valves Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, randomized, open-label, blinded end-point (PROBE) clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2625}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombosis/thromboembolism', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients who have at least one of the following: ischemic stroke, systemic thromboembolism, and valve thrombosis'}, {'measure': 'Major bleeding', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients that have bleeding that results in the following:\n\n1. Death and/or,\n2. Symptomatic bleeding in critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, in a non-operated joint, or intramuscular with compartment syndrome) and/or,\n3. Bleeding that causes drop of hemoglobin level by 20 g/L or more, or that requires the transfusion of 2 or more units of packed red blood cells or whole blood'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline.'}, {'measure': 'All clinically important bleeding', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients that experience all clinically important bleeding (major and minor)'}, {'measure': 'Minor bleeding', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients that experience a bleed that does not meet major bleeding criteria'}, {'measure': 'All stroke', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients that experience a strokes, including ischemic stroke, ischemic with secondary transformation, stroke of uncertain classification and hemorrhagic stroke'}, {'measure': 'Ischemic stroke', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients that experience an ischemic stroke, defined as focal brain infarction caused by an arterial (or rarely venous) obstruction and as documented by CT/MRI that is normal or shows an infarct in the clinicall expected area'}, {'measure': 'Hemorrhagic stroke', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients that experience a hemorrhagic stroke, defined as requiring neuroimaging or autopsy confirmation, and includes two subcategories: primary intracerebral hemorrhage and primary subarachnoid hemorrhage'}, {'measure': 'Type 1, 2 or 3 myocardial infarction', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients who experience a type 1, 2 or 3 myocardial infarction'}, {'measure': 'Systemic thromboembolism', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients who experience a systemic thromboembolism'}, {'measure': 'Valve thrombosis', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients who experience a valve thrombosis'}, {'measure': 'Pulmonary embolism', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients who experience a pulmonary embolism'}, {'measure': 'Deep vein thrombosis', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients who experience a deep vein thrombosis'}, {'measure': 'New renal replacement therapy', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'Number of patients requiring new renal replacement therapy'}, {'measure': 'Time in therapeutic range', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': "The percentage of time the patient's INR was within the target range"}, {'measure': 'Proportion of patients with extreme INR values (>4)', 'timeFrame': 'Through study completion, an expected mean of 2-3 years', 'description': 'The proportion of patients with at least one reported INR value above 4'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mechanical valve replacement', 'Vitamin K antagonist', 'INR targets', 'Bleeding', 'Thromboembolism'], 'conditions': ['Bleeding Post-mechanical Valve Replacement', 'Thromboembolism Post-mechanical Valve Replacement']}, 'referencesModule': {'references': [{'pmid': '24512654', 'type': 'BACKGROUND', 'citation': 'Puskas J, Gerdisch M, Nichols D, Quinn R, Anderson C, Rhenman B, Fermin L, McGrath M, Kong B, Hughes C, Sethi G, Wait M, Martin T, Graeve A; PROACT Investigators. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.'}, {'pmid': '20598989', 'type': 'BACKGROUND', 'citation': 'Torella M, Torella D, Chiodini P, Franciulli M, Romano G, De Santo L, De Feo M, Amarelli C, Sasso FC, Salvatore T, Ellison GM, Indolfi C, Cotrufo M, Nappi G. LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial. Am Heart J. 2010 Jul;160(1):171-8. doi: 10.1016/j.ahj.2010.05.005.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.', 'detailedDescription': "Warfarin (Coumadin) is a blood thinner used to prevent blood clot formation in patients with mechanical heart valves. Blood clots can block blood flow to the brain, heart, or other parts of the body. Mechanical heart valves increases the risk of clot so patients with a mechanical heart valve must take warfarin to reduce their risk of stroke and other blood clot-related problems.\n\nThe degree to which warfarin 'works' varies from person to person, and so dosage is determined by measuring each person's response to the drug as an 'international normalized ratio' or INR. A patient with an INR over 1.0 has blood that takes longer to clot than average, and increasing INR values represent increasing time required for blood to clot. While an INR over 1.0 decreases clotting risk, it also increases bleeding risk. It is important to carefully balance these risks.\n\nSpecific INR targets have been recommended for patients with a mechanical heart valve, but these recommendations differ between scientific groups and are based on low quality evidence. Recent studies suggest that a lower INR target range than is currently recommended can be used safely. A laboratory study showed that warfarin effectively prevents blood clot formation on mechanical heart valves as long as the INR is 1.5 or above. Two moderately-sized clinical studies showed that an INR target range of 1.5-2.5 resulted in less bleeding than the usual higher target range without increasing blood clot formation or stroke in patients with a newer valve model. Whether we could use a lower INR target range for patients with a mechanical aortic valve remains controversial.\n\nThis study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age is 18 or older at the time of enrolment\n* Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago\n* Written informed consent from either the patient or substitute decision maker\n\nExclusion criteria:\n\n* Has a second implanted mechanical valve (any position)\n* Lower boundary of planned INR range is less than 2.0\n* Pregnant or expecting to become pregnant during the study follow-up'}, 'identificationModule': {'nctId': 'NCT03636295', 'acronym': 'LIMIT', 'briefTitle': 'Low INR to Minimize Bleeding With Mechanical Valves Trial', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Low INR to Minimize Bleeding With Mechanical Valves Trial', 'orgStudyIdInfo': {'id': '5139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced INR Target', 'description': 'Warfarin therapy will be titrated to a target INR in the range of 1.5 to 2.5.', 'interventionNames': ['Drug: Warfarin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard INR Target', 'description': 'Warfarin therapy will be titrated to a "standard of care" target INR range.', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin'], 'description': 'Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.', 'armGroupLabels': ['Reduced INR Target', 'Standard INR Target']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Philippe Bertrand, MD', 'role': 'CONTACT'}, {'name': 'Philippe Bertrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Filip Rega, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Ziekenhuis Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Gaborone', 'status': 'RECRUITING', 'country': 'Botswana', 'contacts': [{'name': 'Julius Mwita, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Botswana, at Princess Marina Hospital', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'zip': '83430-000', 'city': 'Campina Grande do Sul', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Dalton Precoma, MD', 'role': 'CONTACT'}, {'name': 'Dalton Precoma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sociedade Hospitalar Angelina Caron', 'geoPoint': {'lat': -25.30556, 'lon': -49.05528}}, {'zip': '89204-250', 'city': 'Joinville', 'state': 'Santa Catarina', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Conrado R. Hoffmann Filho, MD', 'role': 'CONTACT'}, {'name': 'Conrado R. Hoffmann Filho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HEW Cardiologia LTDA', 'geoPoint': {'lat': -26.30444, 'lon': -48.84556}}, {'zip': '05403-000', 'city': 'Cerqueira César', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Roney Sampaio, MD', 'role': 'CONTACT'}, {'name': 'Roney Sampaio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'InCor-HCFMUSP', 'geoPoint': {'lat': -23.03556, 'lon': -49.16611}}, {'city': 'Brasília', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Kaytussia Sena', 'role': 'CONTACT'}, {'name': 'Adegil Silva, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mayara Silva', 'role': 'CONTACT'}, {'name': 'Auristela Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dante Pazzanese Institute of Cardiology', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Kumbo', 'status': 'RECRUITING', 'country': 'Cameroon', 'contacts': [{'name': 'Tantchou Tchoumi Jacques Cabral, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Elizabeth Catholic General Hospital', 'geoPoint': {'lat': 6.2, 'lon': 10.66667}}, {'zip': 'B3S 0H6', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Robbie Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Emilie Belley-Cote, MD', 'role': 'CONTACT', 'email': 'emilie.belley-cote@phri.ca', 'phone': '905-527-4322', 'phoneExt': '40306'}], 'facility': 'Hamilton General Hospital', 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'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaolu Sun, MD', 'role': 'CONTACT'}, {'name': 'Yan Liang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fuwai Hospital, CAMS & PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '6200', 'city': 'Aabenraa', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michael S Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Jutland Hospital', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'zip': '8200', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Erik Grove, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '07747', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Torsten Doenst, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '73100', 'city': 'Lecce', 'state': 'Apulia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Santarpino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Città di Lecce Hospital', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '71122', 'city': 'Foggia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Paparella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gaetano Serviddio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '44600', 'city': 'Kathmandu', 'state': 'Bagmati', 'status': 'RECRUITING', 'country': 'Nepal', 'contacts': [{'name': 'Raamesh Koirala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shahid Gangalal National Heart Centre', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}, {'zip': '56700', 'city': 'Dharān', 'state': 'Koshi', 'status': 'RECRUITING', 'country': 'Nepal', 'contacts': [{'name': 'Sanjib Kumar Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BP Koirala Institute of Health Sciences', 'geoPoint': {'lat': 26.81436, 'lon': 87.27972}}, {'zip': '3015', 'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jolien Roos-Hesselink, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus University Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '44000', 'city': 'Islamabad', 'state': 'Capital Territory', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Asghar Nawaz, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shifa Clinical Research Center', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander Bogachev-Prokophiev, MD', 'role': 'CONTACT'}], 'facility': 'Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Eman Alrajhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Faisal Specialist Hospital & Research Centre', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Gumi', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hun-Gyu Hwang, MD', 'role': 'CONTACT'}, {'name': 'Hun-Gyu Hwang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soonchunhyang University Gumi Hospital', 'geoPoint': {'lat': 36.1136, 'lon': 128.336}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ekaterine Popova, MD', 'role': 'CONTACT'}, {'name': 'Juan Carles Souto Andres, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'G81 4HX', 'city': 'Clydebank', 'state': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nawwar Al-Attar, FRCS, FETCS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.90137, 'lon': -4.4057}}, {'city': 'Middlesbrough', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Carmen Neave', 'role': 'CONTACT'}, {'name': 'Enoch Akowuah, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Austin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}], 'centralContacts': [{'name': 'Emilie Belley-Côté, MD, MSc', 'role': 'CONTACT', 'email': 'emilie.belley-cote@phri.ca', 'phone': '905-527-4322', 'phoneExt': '40306'}, {'name': 'Richard Whitlock, MD, PhD', 'role': 'CONTACT', 'email': 'richard.whitlock@phri.ca', 'phone': '905-527-4322', 'phoneExt': '40306'}], 'overallOfficials': [{'name': 'Emilie Belley-Côté, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will establish a plan for the full-scale study but there is no plan to make IPD available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emilie Belley-Cote', 'investigatorAffiliation': 'Population Health Research Institute'}}}}