Table 1.
Clinical studies comprising the XANTUS program
| Studya | XANTUSb | XANTUS-EL | XANAPc | XANTUS-CN |
|---|---|---|---|---|
| NCT identifier | NCT01606995 | NCT01800006 | NCT01750788 | Not yet available |
| Estimated enrollment | 6,000 | At least 10,000 patients expected across all three studies | ||
| First patient, first visit (date) | June 12, 2012 | July 18, 2013 | February 6, 2013 | In planning |
| Primary geographic region | European union, plus enrollment in Canada | Eastern Europe, Eastern Mediterranean, Middle East, Latin America | Asia-Pacific | People’s Republic of china |
Notes:
All studies will use the same design, database, and adjudication procedures;
the parent study and subject of this paper;
the East Asia subanalysis of ROCKET AF demonstrated that the 20 mg once-daily dose did not need to be adjusted in patients in this region, and that results from the East Asian population were consistent with those from the overall study.17
Abbreviations: XANTUS, Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation; XANTUS-EL, Xarelto® for Prevention of Stroke in Patients with Nonvalvular Atrial Fibrillation, Eastern Europe, Middle East, Africa and Latin America; XANAP, Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific; XANTUS-CN, Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation – China.