RecruitingPhase 3NCT03636295

Low INR to Minimize Bleeding With Mechanical Valves Trial

Sponsor

Population Health Research Institute

Enrollment

2,625 participants

Start Date

Sep 5, 2019

Study Type

INTERVENTIONAL

Conditions

Bleeding Post-mechanical Valve Replacement Thromboembolism Post-mechanical Valve Replacement

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Warfarin for people with bleeding post-mechanical valve replacement and thromboembolism post-mechanical valve replacement. The study is currently recruiting participants at 35 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWarfarin

Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.

Locations(35)

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

AZ Oostende

Ostend, West-Vlaanderen, Belgium

Imelda Hospital

Keerbergen, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

University of Botswana, at Princess Marina Hospital

Gaborone, Botswana

Sociedade Hospitalar Angelina Caron

Campina Grande do Sul, Paraná, Brazil

HEW Cardiologia LTDA

Joinville, Santa Catarina, Brazil

InCor-HCFMUSP

Cerqueira César, São Paulo, Brazil

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

Brasília, Brazil

Dante Pazzanese Institute of Cardiology

São Paulo, Brazil

St. Elizabeth Catholic General Hospital

Kumbo, Cameroon

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

London Health Sciences Centre Research Inc.

London, Ontario, Canada

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Fuwai Hospital, CAMS & PUMC

Beijing, China

Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark

Esbjerg, Region Syddanmark, Denmark

Southern Jutland Hospital

Aabenraa, Denmark

Aarhus University Hospital

Aarhus, Denmark

Universitätsklinikum Jena

Jena, Germany

Città di Lecce Hospital

Lecce, Apulia, Italy

Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia

Foggia, Italy

Shahid Gangalal National Heart Centre

Kathmandu, Bagmati, Nepal

Nobel Medical College and Teaching Hospital

Biratnagar, Koshi, Nepal

BP Koirala Institute of Health Sciences

Dharān, Koshi, Nepal

Erasmus University Medical Centre

Rotterdam, Netherlands

Shifa Clinical Research Center

Islamabad, Capital Territory, Pakistan

Meshalkin National Medical Research Center

Novosibirsk, Russia

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Soonchunhyang University Gumi Hospital

Gumi, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Golden Jubilee National Hospital

Clydebank, Glasgow, United Kingdom

Liverpool Heart & Chest Hospital

Liverpool, United Kingdom

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

Middlesbrough, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03636295