Status:
UNKNOWN
Therapy With New Oral Anticoagulants
Lead Sponsor:
Sheba Medical Center
Conditions:
Atrial Fibrillation
Non-valvular Atrial Fibrillation
Eligibility:
All Genders
21+ years
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 ...
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 show...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT02222090
Start Date
July 1 2014
End Date
July 1 2016
Last Update
August 21 2014
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 5262179