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Study identifier: NCT03636295 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: RecruitingLIMIT

Low INR to Minimize Bleeding With Mechanical Valves Trial

Condition: Bleeding Post-mechanical Valve Replacement · Thromboembolism Post-mechanical Valve Replacement  ·  Sponsor: Population Health Research Institute

PhasePhase 3
Planned participants2625
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where35 locations · 17 countries

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Emilie Belley-Côté, MD, MSc  ·  905-527-4322  ·  emilie.belley-cote@phri.ca

Richard Whitlock, MD, PhD  ·  905-527-4322  ·  richard.whitlock@phri.ca

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (35)

Ziekenhuis Oost-LimburgGenk, Limburg, BelgiumRecruiting
AZ OostendeOstend, West-Vlaanderen, BelgiumRecruiting
Imelda HospitalKeerbergen, BelgiumRecruiting
Universitair Ziekenhuis LeuvenLeuven, BelgiumRecruiting
University of Botswana, at Princess Marina HospitalGaborone, BotswanaRecruiting
Sociedade Hospitalar Angelina CaronCampina Grande do Sul, Paraná, BrazilRecruiting
HEW Cardiologia LTDAJoinville, Santa Catarina, BrazilRecruiting
InCor-HCFMUSPCerqueira César, São Paulo, BrazilRecruiting
Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito FederalBrasília, BrazilRecruiting
Dante Pazzanese Institute of CardiologySão Paulo, BrazilRecruiting
St. Elizabeth Catholic General HospitalKumbo, CameroonRecruiting
Nova Scotia Health AuthorityHalifax, Nova Scotia, CanadaNot Yet Recruiting

+ 23 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

GenkOstendKeerbergenLeuven

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