Therapy With New Oral Anticoagulants
1 other identifier
observational
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 21, 2014
August 1, 2014
1 year
August 4, 2014
August 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Outcomes
To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.
within 12 month from enrollment
Secondary Outcomes (1)
one-year outcomes
within 12 month from enrollment
Study Arms (2)
patients who have been prescribed warfarin
patients who have been prescribed apixaba
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, 5262179, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ilan Goldenberg, Prof
Sheba Medical Center
- PRINCIPAL INVESTIGATOR
Alon Barsheshet, MD
beilinson Medical Center
- PRINCIPAL INVESTIGATOR
Avishay Elias, MD
beilinson Medical Center
- PRINCIPAL INVESTIGATOR
Shmuel Fuchs, Prof
beilinson Medical center
- PRINCIPAL INVESTIGATOR
KIRILL BUTURLIN, MD
Meir Medical Center
- PRINCIPAL INVESTIGATOR
Moshe Swissa, MD
Kaplan Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 21, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2016
Last Updated
August 21, 2014
Record last verified: 2014-08