Therapy With New Oral Anticoagulants

Therapy With New Oral Anticoagulants in Patients With Atrial Fibrillation and Renal Impairment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02222090

Enrollment

1500

Registered

2014-08-21

Start date

2014-07-31

Completion date

2016-07-31

Last updated

2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
one-year outcomes	within 12 month from enrollment	Establish the one-year outcomes of this patient population

Countries

Israel

Contacts

Primary ContactIlan Goldenberg, Prof

Ilan.Goldenberg@sheba.health.gov.il

Outcome results