Circulatory System Cardiology
Conditions
Interventions
The intervention is to titrate a VKA to a target INR in the range of 1.5 to 2.5
The control is to titrate a vitamin K antagonist to a standard of care target INR
Sponsors
Hamilton Health Sciences through its Population Health Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients need to meet the following criteria for inclusion: 1) Have had a bileaflet mechanical heart valve implant in the aortic position at least 3 months ago, 2) Be at least 18 years of age at the time of enrolment, 3) Provide written informed consent (either from the patient or a substitute decision-maker)
Exclusion criteria
Exclusion criteria: Patients will be excluded if they meet any of the following criteria: 1) Have a second implanted mechanical valve (any position) 2) Lower boundary of planned INR range is less than 2.0 3) Pregnant or expecting to be come pregnant during the study follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes are thrombosis/thromboembolism composite of ischemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause-mortality, all clinically important bleeding, minor bleeding, all stroke, ischemic stroke, hemorrhagic stroke, type 1 2 or 3 myocardial infarction, systemic thromboembolism, valve thrombosis, pulmonary embolism, deep vein thrombosis, new renal replacement therapy, time in therapeutic range, proportion of patients with extreme INR values greater than 4 | — |
Countries
Kenya
Contacts
Public ContactLIMIT Project Office
Project Office
Outcome results
None listed