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| ID | Type | Description | Link |
|---|---|---|---|
| FARM9JNT9Y | Other Grant/Funding Number | Agenzia Italiana per il Farmaco (AIFA) | |
| 2012-002578-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Federico II University | OTHER |
| University of Salerno | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin in elderly with comorbidity | Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| number of cardiovascular and cerebrovascular events | composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism |
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Inclusion Criteria:
Exclusion Criteria:
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prospective cohort of elderly people (≥65 years) with nonvalvular atrial fibrillation and/or heart valve replacement, with at least one comorbid condition, presenting for warfarin therapy
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| Name | Affiliation | Role |
|---|---|---|
| Ciro Gallo, MD | University of Campania Luigi Vanvitelli | Study Chair |
| Amelia Filippelli, MD | University of Salerno | Principal Investigator |
| Marisa De Feo, MD | University of Campania Luigi Vanvitelli | Principal Investigator |
| Nicola Ferrara, MD | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second University of Naples | Naples | Italy | ||||
| University of Naples Federico II |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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Whole blood
| 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. | 12 months |
| number of thromboembolic event | thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism. | 12 months |
| number of cardiovascular and cerebrovascular events | 4 weeks |
| number of patient reported episodes of minor bleeding events | one year |
| average maintenance dose per patient | 12 months |
| time to achievement of stable warfarin dosing from initiation | 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 | up to 12 months |
| percentage time in the therapeutic INR range | up to 3 months |
| percentage time in the therapeutic INR range | four weeks |
| Naples |
| Italy |
| University of Salerno | Salerno | Italy |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |