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Low INR to Minimize Bleeding With Mechanical Valves Trial
Sponsor: Population Health Research Institute
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2625
Start Date
2019-09-05
Completion Date
2026-12-31
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
Warfarin
Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.
Locations (35)
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