Low INR to Minimize Bleeding With Mechanical Valves Trial
NCT ID: NCT03636295
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2625 participants
INTERVENTIONAL
2019-09-05
2026-12-31
Brief Summary
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Detailed Description
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The 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.
Specific 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.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Reduced INR Target
Warfarin therapy will be titrated to a target INR in the range of 1.5 to 2.5.
Warfarin
Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.
Standard INR Target
Warfarin therapy will be titrated to a "standard of care" target INR range.
Warfarin
Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.
Interventions
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Warfarin
Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago
* Written informed consent from either the patient or substitute decision maker
Exclusion Criteria
* Lower boundary of planned INR range is less than 2.0
* Pregnant or expecting to become pregnant during the study follow-up
18 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Emilie Belley-Cote
Principal Investigator
Principal Investigators
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Emilie Belley-Côté, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
AZ Oostende
Ostend, West-Vlaanderen, Belgium
Imelda Hospital
Keerbergen, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
University of Botswana, at Princess Marina Hospital
Gaborone, , Botswana
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, Paraná, Brazil
HEW Cardiologia LTDA
Joinville, Santa Catarina, Brazil
InCor-HCFMUSP
Cerqueira César, São Paulo, Brazil
Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, , Brazil
Dante Pazzanese Institute of Cardiology
São Paulo, , Brazil
St. Elizabeth Catholic General Hospital
Kumbo, , Cameroon
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre Research Inc.
London, Ontario, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Fuwai Hospital, CAMS & PUMC
Beijing, , China
Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, Denmark
Southern Jutland Hospital
Aabenraa, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Universitätsklinikum Jena
Jena, , Germany
Città di Lecce Hospital
Lecce, Apulia, Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia
Foggia, , Italy
Shahid Gangalal National Heart Centre
Kathmandu, Bagmati, Nepal
Nobel Medical College and Teaching Hospital
Biratnagar, Koshi, Nepal
BP Koirala Institute of Health Sciences
Dharān, Koshi, Nepal
Erasmus University Medical Centre
Rotterdam, , Netherlands
Shifa Clinical Research Center
Islamabad, Capital Territory, Pakistan
Meshalkin National Medical Research Center
Novosibirsk, , Russia
King Faisal Specialist Hospital & Research Centre
Riyadh, , Saudi Arabia
Soonchunhyang University Gumi Hospital
Gumi, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Golden Jubilee National Hospital
Clydebank, Glasgow, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, , United Kingdom
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Philippe Bertrand, MD
Role: primary
Dalton Precoma, MD
Role: primary
Conrado R. Hoffmann Filho, MD
Role: primary
Roney Sampaio, MD
Role: primary
Kaytussia Sena
Role: primary
Mayara Silva
Role: primary
Linrui Guo, MD
Role: primary
Joseph Shaw, MD
Role: primary
Mark Blostein, MD
Role: primary
Xiaolu Sun, MD
Role: primary
Alexander Bogachev-Prokophiev, MD
Role: primary
Hun-Gyu Hwang, MD
Role: primary
Ekaterine Popova, MD
Role: primary
Carmen Neave
Role: primary
References
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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.
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.
Other Identifiers
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5139
Identifier Type: -
Identifier Source: org_study_id
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