A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Rivaroxaban 20 mg orally once daily for 6 weeks; subjects with severe to moderate renal impairment (ie, CrCl of 15 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily for 6 weeks in the study.
Unnamed facility
Plovdiv, Bulgaria
Unnamed facility
Sofia, Bulgaria
The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment
Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiography
Time frame: After 6 weeks
Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new
Time frame: After 6 weeks
The composite number of stroke and non-central nervous system systemic embolism events
Time frame: Up to 12 weeks
The number of all bleeding events
Time frame: Up to 12 weeks
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Unnamed facility
Sofia, Bulgaria
Unnamed facility
Varna, Bulgaria
Unnamed facility
Créteil, France
Unnamed facility
Marseille, France
Unnamed facility
Paris, France
Unnamed facility
Toulouse, France
Unnamed facility
Hamburg, Hamburg, Germany
Unnamed facility
Bonn, North Rhine-Westphalia, Germany
...and 21 more locations