Atrial Fibrillation, Thrombus Due to Heart Valve Prosthesis
Conditions
Keywords
Warfarin, International Warfarin Pharmacogenetics Consortium algorithm, Atrial Fibrillation, Heart Valve Prosthesis Implantation, elderly, comorbidity
Brief summary
The purpose of this study is to validate the International Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid condition, and to assess the algorithm's prognostic relevance.
Interventions
DRUGWarfarin
warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.
Sponsors
Federico II University
University of Salerno
University of Campania Luigi Vanvitelli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 65 years * Patients who initiate warfarin because of non valvular atrial fibrillation or heart valve replacement * At least one comorbid condition * At least two other drugs regularly assumed over and above warfarin
Exclusion criteria
* Presence of systemic coagulopathies * Presence of malignancies needing chemotherapy * Inability or refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose. | up to 12 months | stable warfarin dosing is defined as the mean daily does required to achieve three or more consecutive International Normalized Ratio (INR) measurements within the individual's target range, at the same daily does. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of cardiovascular and cerebrovascular events | 12 months | composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism |
| number of patients with major bleeding events | 12 months | major bleeding: (i) fatal bleeding; and/or (ii) symptomatic bleeding in a critical area or organ; and/or (iii) bleeding causing a fall in haemoglobin level of ≥2 g/dL or leading to transfusion of two or more units of blood or red cells. |
| number of thromboembolic event | 12 months | thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism. |
| number of patient reported episodes of minor bleeding events | one year | — |
| Percentage of patients for whom the predicted dose is at least 20% higher than the actual dose (overestimation) or at least 20% lower than the actual dose (underestimation). | up to 12 months | — |
| time to achievement of stable warfarin dosing from initiation | up to 12 months | — |
| time to therapeutic INR per patient | up to 12 months | defined as the time of first achieving INR measurement within the individual's target range, providing that INR is also within the target range at the subsequent clinic visit |
| percentage time in the therapeutic INR range | up to 3 months | — |
| average maintenance dose per patient | 12 months | — |
Countries
Italy
Outcome results
None listed