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| Name | Class |
|---|---|
| University of Paris 5 - Rene Descartes | OTHER |
| Sorbonne University | OTHER |
| Assistance Publique - Hôpitaux de Paris | OTHER |
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Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.
Several new oral direct anticoagulants have been recently marketed. A main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study. This is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. Each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. In addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main cohort (only cohort of the study) | Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation. All patients will have plasma drug concentrations measured and will be followed afterwards similarly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma drug concentrations | Other | Measure of plasma concentrations of the anticoagulant drug taken by the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacologic parameters of new oral anticoagulants in elderly patients | Estimated area under the curve (AUC) of each of the 3 drugs studied | 1 to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolic events | Any thromboembolic event (composite of ischemic stroke, systemic embolism or acute coronary syndrome) in the year after inclusion | 1 year |
| Hemorrhagic events | Major hemorrhagic events in the year after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo Lafuente, MD, PhD | Hôpital Charles Foix, APHP, Université Paris 6 UPMC | Principal Investigator |
| Julien Le Guen, MD | Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Charles Foix | Ivry-sur-Seine | Île-de-France Region | 94205 | France | ||
| Hôpital Européen Georges Pompidou |
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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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Blood
| 1 year |
| Paris |
| Île-de-France Region |
| 75015 |
| France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |