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The aim of the present registry is to characterize and follow patients prospectively and retrospectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population.
Current guidelines for the management of patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF .Renal dysfunction has been shown to be an independent predictor of stroke or systemic emboli, but the risk of bleeding with conventional warfarin therapy is also significantly increased.Prevalence of renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of patients having an estimated glomerular filtration rate (eGFR) of ≤ 60 ml/min/BSA [6].NOACs undergoing significant renal secretion such as dabigatran are not recommended for patients with severe renal impairment, and dose adjustment are indicated for patients with milder degrees of renal dysfunction.However, real-world information regarding the usage and outcomes associated with NOAC therapy in patients with renal dysfunction are limited. The investigators plan to prospectively and retrospectively collect data regarding the clinical settings, characteristics, and outcomes of patients with renal dysfunction who have been prescribed apixaban in Israel, using a multicenter secure web-based registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients who have been prescribed warfarin | |||
| patients who have been prescribed apixaba |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes | To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin. | within 12 month from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| one-year outcomes | Establish the one-year outcomes of this patient population | within 12 month from enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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patients prospectively and retropectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Goldenberg, Prof | Contact | Ilan.Goldenberg@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Ilan Goldenberg, Prof | Sheba Medical Center | Study Director |
| Alon Barsheshet, MD | beilinson Medical Center | Principal Investigator |
| Avishay Elias, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | 5262179 | Israel |
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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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| beilinson Medical Center |
| Principal Investigator |
| Shmuel Fuchs, Prof | beilinson Medical center | Principal Investigator |
| KIRILL BUTURLIN, MD | Meir Medical Center | Principal Investigator |
| Moshe Swissa, MD | Kaplan Medical Center | Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |