Lowering INR targets to reduce bleeding in patients with mechanical heart valves
Official title: Low INR to Minimize Bleeding With Mechanical Valves Trial
Run by Population Health Research Institute · NCT03636295 · Data updated 2026-11-12
This study is testing if setting a lower blood clotting target for patients with mechanical heart valves can help reduce bleeding risks without causing more blood clots or strokes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2625 (estimated) |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 45 sites (Genk, Limburg and 44 other locations) |
| Status | Recruiting |
| Started | September 5, 2019 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT03636295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older who have had a bileaflet mechanical heart valve implanted in the aortic position for at least three months.
✕Probably not a fit
Patients with multiple mechanical valves or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a lower INR target range (1.5 to 2.5) in patients who have undergone mechanical bileaflet heart valve replacement in the aortic position. It aims to determine whether this lower target can reduce the risk of bleeding without increasing the risk of thromboembolism or stroke. Participants will be monitored while receiving warfarin (Coumadin) treatment, and the outcomes will help inform clinical guidelines regarding INR management in this patient population.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of bleeding complications in patients with mechanical heart valves.
How similar studies have gone: Previous studies have shown promising results with similar lower INR target approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium Recruiting -
AZ Oostende
Ostend, West-Vlaanderen, Belgium Recruiting -
Imelda Hospital
Keerbergen, Belgium Recruiting -
Universitair Ziekenhuis Leuven
Leuven, Belgium Recruiting -
University of Botswana, at Princess Marina Hospital
Gaborone, Botswana Recruiting -
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, Paraná, Brazil Recruiting
Show 39 more locations
-
HEW Cardiologia LTDA
Joinville, Santa Catarina, Brazil Recruiting -
InCor-HCFMUSP
Cerqueira César, São Paulo, Brazil Recruiting -
Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, Brazil Recruiting -
Hospital de Messejana
Fortaleza, Brazil Recruiting -
Dante Pazzanese Institute of Cardiology
São Paulo, Brazil Recruiting -
Centro de Pesquisa Cardiolima
Teresina, Brazil Recruiting -
Coeur et Vie Clinic
Douala, Cameroon Recruiting -
St. Elizabeth Catholic General Hospital
Kumbo, Cameroon Recruiting -
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada Recruiting -
Hamilton General Hospital
Hamilton, Ontario, Canada Recruiting -
London Health Sciences Centre Research Inc.
London, Ontario, Canada Recruiting -
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada Recruiting -
Jewish General Hospital
Montreal, Quebec, Canada Recruiting -
Fuwai Hospital, CAMS & PUMC
Beijing, China Recruiting -
Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, Denmark Recruiting -
Southern Jutland Hospital
Aabenraa, Denmark Recruiting -
Aarhus University Hospital
Aarhus, Denmark Recruiting -
Justus-Liebig-Universitat
Giessen, Germany Recruiting -
Universitätsklinikum Jena
Jena, Germany Recruiting -
Città di Lecce Hospital
Lecce, Apulia, Italy Recruiting -
AOU SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy Recruiting -
AOU delle Marche
Ancona, Italy Recruiting -
Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia
Foggia, Italy Recruiting -
The Karen Hospital
Nairobi, Kenya Recruiting -
Shahid Gangalal National Heart Centre
Kathmandu, Bagmati, Nepal Recruiting -
Nobel Medical College and Teaching Hospital
Biratnagar, Koshi, Nepal Recruiting -
BP Koirala Institute of Health Sciences
Dharān, Koshi, Nepal Recruiting -
National Academy of Medical Sciences, Bir Hospital
Kathmandu, Nepal Recruiting -
Erasmus University Medical Centre
Rotterdam, Netherlands Recruiting -
Shifa Clinical Research Center
Islamabad, Capital Territory, Pakistan Recruiting -
Meshalkin National Medical Research Center
Novosibirsk, Russia Recruiting -
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia Recruiting -
Soonchunhyang University Gumi Hospital
Gumi, South Korea Recruiting -
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain Recruiting -
Golden Jubilee National Hospital
Clydebank, Glasgow, United Kingdom Recruiting -
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom Recruiting -
Barts Health NHS Trust
London, United Kingdom Recruiting -
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
Middlesbrough, United Kingdom Recruiting -
Sheffield Teaching Hospitals
Sheffield, United Kingdom Recruiting
Study contacts
- Principal investigator: Emilie Belley-Côté, MD, MSc — McMaster University
- Study coordinator: Emilie Belley-Côté, MD, MSc
- Email: emilie.belley-cote@phri.ca
- Phone: 905-527-4322
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.