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.
Study Type
OBSERVATIONAL
Enrollment
376
warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.
Second University of Naples
Napoli, Italy
University of Naples Federico II
Napoli, Italy
University of Salerno
Salerno, Italy
Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
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.
Time frame: up to 12 months
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).
Time frame: up to 12 months
number of cardiovascular and cerebrovascular events
composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism
Time frame: 12 months
number of patients with major bleeding events
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.
Time frame: 12 months
number of thromboembolic event
thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.
Time frame: 12 months
number of cardiovascular and cerebrovascular events
Time frame: 4 weeks
number of patient reported episodes of minor bleeding events
Time frame: one year
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average maintenance dose per patient
Time frame: 12 months
time to achievement of stable warfarin dosing from initiation
Time frame: up to 12 months
time to therapeutic INR per patient
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
Time frame: up to 12 months
percentage time in the therapeutic INR range
Time frame: up to 3 months
percentage time in the therapeutic INR range
Time frame: four weeks