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RECRUITING Phase 3 ClinicalTrials.gov

Low INR to Minimize Bleeding With Mechanical Valves Trial

Sponsor: Population Health Research Institute • ClinicalTrials.gov ID: NCT03636295

Registry updated: 2026-09-17
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Description

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.

Interventions

  • Warfarin (Drug)
    Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.

Eligibility criteria

Inclusion criteria: * Age is 18 or older at the time of enrolment * 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: * Has a second implanted mechanical valve (any position) * Lower boundary of planned INR range is less than 2.0 * Pregnant or expecting to become pregnant during the study follow-up

Conditions

Bleeding Post-mechanical Valve Replacement Thromboembolism Post-mechanical Valve Replacement

Locations

  • 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
  • Hospital de Messejana — Fortaleza, Brazil
  • Dante Pazzanese Institute of Cardiology — São Paulo, Brazil
  • Centro de Pesquisa Cardiolima — Teresina, Brazil
  • Coeur et Vie Clinic — Douala, Cameroon
  • 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
  • Justus-Liebig-Universitat — Giessen, Germany
  • Universitätsklinikum Jena — Jena, Germany
  • Città di Lecce Hospital — Lecce, Apulia, Italy
  • AOU SS Antonio e Biagio e Cesare Arrigo — Alessandria, Italy
  • AOU delle Marche — Ancona, Italy
  • Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia — Foggia, Italy
  • The Karen Hospital — Nairobi, Kenya
  • 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
  • National Academy of Medical Sciences, Bir Hospital — Kathmandu, 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
  • Barts Health NHS Trust — London, United Kingdom
  • South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital — Middlesbrough, United Kingdom
  • Sheffield Teaching Hospitals — Sheffield, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record