Status:
COMPLETED
Apixaban in Adults With Congenital Heart Disease and Atrial Arrhythmias: the PROTECT-AR Study
Lead Sponsor:
AHEPA University Hospital
Collaborating Sponsors:
Onassis Cardiac Surgery Centre
Attikon Hospital
Conditions:
Congenital Heart Disease
Atrial Arrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of apixaban for the prevention of thromboembolism in adult patients with congenital heart disease (CHD) and non-valvular atrial arrhyth...
Detailed Description
Adult patients with congenital heart disease (ACHD) represent a rapidly growing population due to the progress of surgical techniques and optimal medical management. Non-valvular atrial arrhythmias (A...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥18 years.
- Presence of congenital heart disease (intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle or other congenital heart disease).
- Non-Valvular Atrial Arrhythmia (including at least one electrocardiographically documented episode).
- Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule.
Exclusion
- moderate-to-severe mitral stenosis or mechanical valves
- patient unwilling or unable to complete follow-up procedures
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT03854149
Start Date
July 1 2019
End Date
May 30 2023
Last Update
June 22 2023
Active Locations (4)
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1
Attikon University Hospital
Athens, Greece, 12462
2
Mitera Children's Hospital
Athens, Greece, 15123
3
Onassis Cardiac Surgery Centre
Athens, Greece, 17674
4
AHEPA University Hospital
Thessaloniki, Greece, 54636