Clinical trial NCT02222090: Therapy With New Oral Anticoagulants
Official title: Therapy With New Oral Anticoagulants in Patients With Atrial Fibrillation and Renal Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Non-valvular Atrial Fibrillation
Keywords: patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-08-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with renal dysfunction (eGFR \<60 ml\\min\\BSA) who have an indication for treatment with an novel oral anticoagulant agent or VKA
* Patients prescribed apixaban or warfarin at the enrollment center (patients enrolled in a 2:1 ratio)

Exclusion Criteria:

* Valvular AF or presence prosthetic valve
* Dialysis patients
* Contraindications NOACs
* Hepatic dysfunction
* Cognitive impairment
* Clinical necessity to continue administration of potent inhibitors of both CYP3A4 and P-gp - including azole- antimycotics (e.g. ketoconazole, itraconazole) and HIV protease inhibitors (e.g. ritonavir)

Primary outcomes:
measure: Clinical Outcomes
timeFrame: within 12 month from enrollment
Secondary outcomes:
measure: one-year outcomes
timeFrame: within 12 month from enrollment
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ilan Goldenberg, Prof
role: STUDY_DIRECTOR
affiliation: beilinson Medical Center
name: Alon Barsheshet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: beilinson Medical Center
name: Avishay Elias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: beilinson Medical center
name: Shmuel Fuchs, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: KIRILL BUTURLIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaplan Medical Center
name: Moshe Swissa, MD
role: PRINCIPAL_INVESTIGATOR
References: