A Phase 3 interventional study of Rivaroxaban (Xarelto, BAY59-7939) in Atrial Fibrillation, sponsored by Bayer. Completed at 31 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-25.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 60 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Rivaroxaban (Xarelto, BAY59-7939)
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.
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
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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