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Could a lower warfarin dose cut bleeding risk in valve patients?

NCT ID NCT03636295

Disease control Sponsor: Population Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests whether a lower target for blood thinning (INR 1.5 to 2.5) can reduce bleeding in people with a mechanical heart valve in the aortic position, without raising the risk of dangerous clots. About 2,625 participants who have had their valve for at least 3 months will be assigned to either the lower or standard INR range. The goal is to find a safer balance between preventing strokes and avoiding serious bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
warfarin (Coumadin)
What this could lead to
If successful, this could lead to a safer, lower-dose warfarin regimen that reduces bleeding complications for people with mechanical heart valves.
What could go wrong
This is a large phase 3 trial, but lowering the INR target might increase the risk of blood clots or stroke. Results may not apply to patients with valves in other positions or those with additional mechanical valves.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,625 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hemorrhage Thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bleeding post-mechanical valve replacement Thromboembolism post-mechanical valve replacement

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    45 sites in 18 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU SS Antonio e Biagio e Cesare Arrigo

    RECRUITING

    Alessandria, Italy

  • AOU delle Marche

    RECRUITING

    Ancona, Italy

  • AZ Oostende

    RECRUITING

    Ostend, West-Vlaanderen, 8400, Belgium

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia

    RECRUITING

    Foggia, 71122, Italy

  • BP Koirala Institute of Health Sciences

    RECRUITING

    Dharān, Koshi, 56700, Nepal

  • Barts Health NHS Trust

    RECRUITING

    London, United Kingdom

  • Centro de Pesquisa Cardiolima

    RECRUITING

    Teresina, Brazil

    Contact Email: •••••@•••••

  • Città di Lecce Hospital

    RECRUITING

    Lecce, Apulia, 73100, Italy

  • Coeur et Vie Clinic

    RECRUITING

    Douala, Cameroon

  • Dante Pazzanese Institute of Cardiology

    RECRUITING

    São Paulo, Brazil

  • Erasmus University Medical Centre

    RECRUITING

    Rotterdam, 3015, Netherlands

  • Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark

    RECRUITING

    Esbjerg, Region Syddanmark, 6700, Denmark

  • Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal

    RECRUITING

    Brasília, Brazil

  • Fuwai Hospital, CAMS & PUMC

    RECRUITING

    Beijing, China

  • Golden Jubilee National Hospital

    RECRUITING

    Clydebank, Glasgow, G81 4HX, United Kingdom

  • HEW Cardiologia LTDA

    RECRUITING

    Joinville, Santa Catarina, 89204-250, Brazil

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Hospital de Messejana

    RECRUITING

    Fortaleza, Brazil

    Contact Email: •••••@•••••

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Imelda Hospital

    RECRUITING

    Keerbergen, 2820, Belgium

  • InCor-HCFMUSP

    RECRUITING

    Cerqueira César, São Paulo, 05403-000, Brazil

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Justus-Liebig-Universitat

    RECRUITING

    Giessen, Germany

  • King Faisal Specialist Hospital & Research Centre

    RECRUITING

    Riyadh, Saudi Arabia

  • Liverpool Heart & Chest Hospital

    RECRUITING

    Liverpool, L143PE, United Kingdom

  • London Health Sciences Centre Research Inc.

    RECRUITING

    London, Ontario, N6C 2R5, Canada

  • Meshalkin National Medical Research Center

    RECRUITING

    Novosibirsk, Russia

  • National Academy of Medical Sciences, Bir Hospital

    RECRUITING

    Kathmandu, Nepal

  • Nobel Medical College and Teaching Hospital

    RECRUITING

    Biratnagar, Koshi, 56613, Nepal

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3S 0H6, Canada

  • Shahid Gangalal National Heart Centre

    RECRUITING

    Kathmandu, Bagmati, 44600, Nepal

  • Sheffield Teaching Hospitals

    RECRUITING

    Sheffield, United Kingdom

  • Shifa Clinical Research Center

    RECRUITING

    Islamabad, Capital Territory, 44000, Pakistan

  • Sociedade Hospitalar Angelina Caron

    RECRUITING

    Campina Grande do Sul, Paraná, 83430-000, Brazil

  • Soonchunhyang University Gumi Hospital

    RECRUITING

    Gumi, South Korea

  • South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital

    RECRUITING

    Middlesbrough, United Kingdom

  • Southern Jutland Hospital

    RECRUITING

    Aabenraa, 6200, Denmark

  • St. Elizabeth Catholic General Hospital

    RECRUITING

    Kumbo, Cameroon

  • The Karen Hospital

    RECRUITING

    Nairobi, Kenya

  • The Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of Botswana, at Princess Marina Hospital

    RECRUITING

    Gaborone, Botswana

  • Universitätsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, Limburg, 3600, Belgium