Actively Recruiting
Low INR to Minimize Bleeding With Mechanical Valves Trial
Led by Population Health Research Institute · Updated on 2026-01-06
2625
Participants Needed
35
Research Sites
382 weeks
Total Duration
On this page
Sponsors
P
Population Health Research Institute
Lead Sponsor
H
Hamilton Health Sciences Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low INR to Minimize Bleeding With Mechanical Valves Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Has a second implanted mechanical valve in any position
- Lower boundary of planned INR range is less than 2.0
- Pregnant or expecting to become pregnant during the study follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Actively Recruiting
2
AZ Oostende
Ostend, West-Vlaanderen, Belgium, 8400
Actively Recruiting
3
Imelda Hospital
Keerbergen, Belgium, 2820
Actively Recruiting
4
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
5
University of Botswana, at Princess Marina Hospital
Gaborone, Botswana
Actively Recruiting
6
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, Paraná, Brazil, 83430-000
Actively Recruiting
7
HEW Cardiologia LTDA
Joinville, Santa Catarina, Brazil, 89204-250
Actively Recruiting
8
InCor-HCFMUSP
Cerqueira César, São Paulo, Brazil, 05403-000
Actively Recruiting
9
Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, Brazil
Actively Recruiting
10
Dante Pazzanese Institute of Cardiology
São Paulo, Brazil
Actively Recruiting
11
St. Elizabeth Catholic General Hospital
Kumbo, Cameroon
Actively Recruiting
12
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3S 0H6
Not Yet Recruiting
13
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
14
London Health Sciences Centre Research Inc.
London, Ontario, Canada, N6C 2R5
Actively Recruiting
15
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
16
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
17
Fuwai Hospital, CAMS & PUMC
Beijing, China
Actively Recruiting
18
Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, Denmark, 6700
Actively Recruiting
19
Southern Jutland Hospital
Aabenraa, Denmark, 6200
Actively Recruiting
20
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
21
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
22
Città di Lecce Hospital
Lecce, Apulia, Italy, 73100
Actively Recruiting
23
Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia
Foggia, Italy, 71122
Actively Recruiting
24
Shahid Gangalal National Heart Centre
Kathmandu, Bagmati, Nepal, 44600
Actively Recruiting
25
Nobel Medical College and Teaching Hospital
Biratnagar, Koshi, Nepal, 56613
Actively Recruiting
26
BP Koirala Institute of Health Sciences
Dharān, Koshi, Nepal, 56700
Actively Recruiting
27
Erasmus University Medical Centre
Rotterdam, Netherlands, 3015
Actively Recruiting
28
Shifa Clinical Research Center
Islamabad, Capital Territory, Pakistan, 44000
Actively Recruiting
29
Meshalkin National Medical Research Center
Novosibirsk, Russia
Actively Recruiting
30
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia
Actively Recruiting
31
Soonchunhyang University Gumi Hospital
Gumi, South Korea
Actively Recruiting
32
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
33
Golden Jubilee National Hospital
Clydebank, Glasgow, United Kingdom, G81 4HX
Actively Recruiting
34
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom, L143PE
Actively Recruiting
35
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
Middlesbrough, United Kingdom
Actively Recruiting
Research Team
E
Emilie Belley-Côté, MD, MSc
CONTACT
R
Richard Whitlock, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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