bleeding post-mechanical valve replacement
Conditions
Interventions
All enrolled patients will already be taking a VKA according to typical care.
The intervention group will receive a dose titrated to achieve an INR target of
1.5 to 2.5. The control group will recei
Sponsors
Population Health Research Institute
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Have had a bileaflet mechanical heart valve implant in the aortic position >=3 months ago, 2) Be >=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: 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 become pregnant during the study follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the incidence of major bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| The most important secondary outcome is all thrombosis/thromboembolism (composite of ischemic stroke, systemic thromboembolism, valve thrombosis). Other secondary outcomes include: 1) All-cause mortality (selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline) 2) All bleeding 3) Minor bleeding 4) All stroke 5) Ischemic stroke 6) Hemorrhagic stroke 7) Type 1, 2 or 3 myocardial infarction 8) Systemic thromboembolism 9) Valve thrombosis 10) Pulmonary embolism 11) Deep vein thrombosis 12) New renal replacement therapy 13) Time in therapeutic range 14) Proportion of patients with extreme INR values (>4) | — |
Countries
Netherlands
Outcome results
None listed