Therapy With New Oral Anticoagulants

• Conditions: Non-valvular Atrial Fibrillation; Atrial Fibrillation

• Registration Number: NCT02222090
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-20
• Last Update Submitted: 2014-08-20
• Study First Posted: 2014-08-21
• Last Update Posted: 2014-08-21
• Primary Completion: 2015-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes	within 12 month from enrollment	To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.

Secondary Outcome Measures

Name	Time	Method
one-year outcomes	within 12 month from enrollment	Establish the one-year outcomes of this patient population

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel