Low INR to Minimize Bleeding With Mechanical Valves Trial
Launched by POPULATION HEALTH RESEARCH INSTITUTE · Aug 15, 2018
Trial Information
Current as of November 13, 2025
Recruiting
Keywords
ClinConnect Summary
The Low INR to Minimize Bleeding With Mechanical Valves Trial is a study looking at whether keeping a lower level of blood thinning (called INR) helps people with a specific type of heart valve replacement avoid serious bleeding without increasing the risk of blood clots or strokes. Participants in this trial will have a bileaflet mechanical heart valve in their aorta and will be monitored to see if an INR target of 1.5 to 2.5 is safe and effective for them.
To join this study, you need to be at least 18 years old and have had your heart valve replacement for at least three months. You cannot have another mechanical valve or be pregnant. If you decide to participate, you'll receive careful follow-up and support throughout the trial. This research could help improve treatment options for patients with mechanical heart valves who need long-term blood thinners, making their experiences safer and more manageable.
Gender
ALL
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
About Population Health Research Institute
The Population Health Research Institute (PHRI) is a leading clinical research organization dedicated to advancing the understanding of population health through innovative research methodologies. With a focus on large-scale, multi-center clinical trials and epidemiological studies, PHRI aims to address pressing health challenges by investigating the interplay between lifestyle, genetic, and environmental factors. By fostering collaboration among researchers, healthcare providers, and communities, PHRI strives to generate evidence-based insights that inform public health policies and improve health outcomes on a global scale. Their commitment to excellence in research is underscored by a robust infrastructure and a multidisciplinary team of experts dedicated to translating research findings into actionable solutions for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, Spain
Hamilton, Ontario, Canada
Aarhus, Denmark
Montréal, Quebec, Canada
Jena, Germany
Leuven, Belgium
Genk, Limburg, Belgium
Sao Paulo, Brazil
Riyadh, Saudi Arabia
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Novosibirsk, Russian Federation
Halifax, Nova Scotia, Canada
Campina Grande Do Sul, Parana, Brazil
Rotterdam, Netherlands
Clydebank, Glasgow, United Kingdom
London, Ontario, Canada
Beijing, China
Joinville, Santa Catarina, Brazil
Cerqueira César, São Paulo, Brazil
Brasilia, Brazil
Gumi, Korea, Republic Of
Middlesbrough, United Kingdom
Cerqueira César, Brazil
Gaborone, Botswana
Aabenraa, Denmark
Lecce, Puglia, Italy
Foggia, Italy
Patients applied
Trial Officials
Emilie Belley-Côté, MD, MSc
Principal Investigator
McMaster University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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