Therapy With New Oral Anticoagulants

NCT ID: NCT02222090

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Atrial Fibrillation; Non-valvular Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients who have been prescribed warfarin

No interventions assigned to this group

patients who have been prescribed apixaba

No interventions assigned to this group

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilan Goldenberg, Prof

Role: STUDY_DIRECTOR

Sheba Medical Center

Alon Barsheshet, MD

Role: PRINCIPAL_INVESTIGATOR

beilinson Medical Center

Avishay Elias, MD

Role: PRINCIPAL_INVESTIGATOR

beilinson Medical Center

Shmuel Fuchs, Prof

Role: PRINCIPAL_INVESTIGATOR

beilinson Medical center

KIRILL BUTURLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Moshe Swissa, MD

Role: PRINCIPAL_INVESTIGATOR

Kaplan Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilan Goldenberg, Prof

Role: CONTACT

Ilan.Goldenberg@sheba.health.gov.il

Facility Contacts

Ilan Goldenberg, MD

Role: primary

ilan.goldenberg@sheba.health.gov.il

972-5302848

Other Identifiers

SHEBA-14-1181-IG-CTIL

Identifier Type: -

Identifier Source: org_study_id