Low INR to Minimize Bleeding With Mechanical Valves Trial
Recruiting now · Phase 3
Conditions studied: Bleeding Post-mechanical Valve Replacement, Thromboembolism Post-mechanical Valve Replacement
In brief
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 facts
- Study ID
- NCT03636295
- Run by
- Population Health Research Institute
- People needed
- 2625
- Starts
- 2019-09-05
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital — Middlesbrough, United Kingdom (enrolling)
- AZ Oostende — Ostend, West-Vlaanderen, Belgium (enrolling)
- Imelda Hospital — Keerbergen, Belgium (enrolling)
- Universitair Ziekenhuis Leuven — Leuven, Belgium (enrolling)
- University of Botswana, at Princess Marina Hospital — Gaborone, Botswana (enrolling)
- Sociedade Hospitalar Angelina Caron — Campina Grande do Sul, Paraná, Brazil (enrolling)
- HEW Cardiologia LTDA — Joinville, Santa Catarina, Brazil (enrolling)
- InCor-HCFMUSP — Cerqueira César, São Paulo, Brazil (enrolling)
- Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal — Brasília, Brazil (enrolling)
- Dante Pazzanese Institute of Cardiology — São Paulo, Brazil (enrolling)
- St. Elizabeth Catholic General Hospital — Kumbo, Cameroon (enrolling)
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (enrolling)
- Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
- London Health Sciences Centre Research Inc. — London, Ontario, Canada (enrolling)
- The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
- Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
- Fuwai Hospital, CAMS & PUMC — Beijing, China (enrolling)
- Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark — Esbjerg, Region Syddanmark, Denmark (enrolling)
- Southern Jutland Hospital — Aabenraa, Denmark (enrolling)
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Universitätsklinikum Jena — Jena, Germany (enrolling)
- Città di Lecce Hospital — Lecce, Apulia, Italy (enrolling)
- Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia — Foggia, Italy (enrolling)
- Shahid Gangalal National Heart Centre — Kathmandu, Bagmati, Nepal (enrolling)
- Nobel Medical College and Teaching Hospital — Biratnagar, Koshi, Nepal (enrolling)
Full record on ClinicalTrials.gov
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