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

NCT ID NCT03636295

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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

Contacts and locations

Locations

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
Città di Lecce Hospital
RECRUITING

Lecce, Apulia, 73100, Italy
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 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
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
Nobel Medical College and Teaching Hospital
RECRUITING

Biratnagar, Koshi, 56613, Nepal
Nova Scotia Health Authority
NOT_YET_RECRUITING

Halifax, Nova Scotia, B3S 0H6, Canada
Shahid Gangalal National Heart Centre
RECRUITING

Kathmandu, Bagmati, 44600, Nepal
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 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