Status:
COMPLETED
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Lead Sponsor:
National Research Center for Preventive Medicine
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale. Primary Study Objective(s) Primary study objective The aim ...
Detailed Description
AF patients from ongoing PROFILE registry will be invited to visit the scientific center. 2 visits with a 6-month interval are expected for each patient as part of routine clinical practice and phone...
Eligibility Criteria
Inclusion
- Men and women above 18 years of age who were included in the PROFILE registry by the start of the observational study
- Presence of written informed consent to participate in the study, fill in the study questionnaires and have personal data analyzed
- Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK
Exclusion
- Patients with high bleeding risk, including patients with:
- Congenital or acquired bleeding disorders
- Uncontrolled resistant hypertension
- Exacerbation of gastric and duodenal ulcer
- Vascular retinopathy
- Recent history of intracranial or intracerebral hemorrhage
- Pathology of the brain and spinal cord vessels
- Recent history of brain, spinal cord or eye surgery
- History of bronchiectasis or pulmonary hemorrhage
- A CHA2DS2-VASc score of 0 (OACs are not indicated)
- Pregnancy, lactation
- Planned surgery
- Known hypersensitivity to ingredients of medications used in the study
Key Trial Info
Start Date :
September 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03790917
Start Date
September 5 2017
End Date
December 28 2018
Last Update
July 16 2020
Active Locations (1)
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1
National Research Center for Preventive Medicine
Moscow, Russia, 101990