Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03410706
Status:
COMPLETED
Last Update Posted:
2022-12-27
First Post:
2018-01-19
Brief Title:
Xarelto for Real Life Anticoagulation in Pulmonary Embolism PE in China
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Xarelto for Real Life Anticoagulation in Pulmonary Embolism PE in China
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XAPEC
Brief Summary:
EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51 relative risk reduction of major bleeding 11 vs 22 HR 049 95 CI 031-079 in the treatment and secondary prevention of PE However these patients were required to meet strict eligibility criteria Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None