Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:September 20, 2016
End Date:December 31, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants

The primary objectives of this study are to compare the risk of major bleeding and
stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial
fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban
treatment.


Inclusion Criteria:

1. Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban
during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy
claim date during the identification period will be designated as the index date

2. Patients 18 years old or older as of the index date

3. At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by
any medical claim

4. At least 12 months of baseline period prior to index date with continuous enrollment

Exclusion Criteria:

1. Evidence of valvular heart disease, transient atrial fibrillation, venous
thromboembolism during the 12-month baseline period or on the index date

2. Evidence of pregnancy during the study period

3. Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban
during the 12-month baseline period

4. Had more than 1 oral anticoagulant claim on the index date
We found this trial at
1
site
Statinmed Research
211 North 4th Avenue
Ann Arbor, Michigan 48104
?
mi
from
Ann Arbor, MI
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