Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440044
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-05-28
Brief Title:
Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism
Status:
COMPLETED
Status Verified Date:
2024-05
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:
None
Brief Summary:
Patients with colorectal cancer CRC have a higher risk of both venous thromboembolism VTE and major bleeding MB Patients with CRC are underrepresented in the major trials examining treatment of cancer-associated VTE with anticoagulant
Detailed Description:
Patients with colorectal cancer CRC have a higher risk of both venous thromboembolism VTE and major bleeding MB Specifically a subsequent analysis of the Hokusai study showed that the excess in MB was confined to patients with gastrointestinal cancer In the RIETE registry patients with gastrointestinal or genitourinary cancers experienced more bleeding outcomes while patients with brain or lung cancer experienced more thrombotic outcomes However in a subgroup analysis of the Caravaggio trial major gastrointestinal bleeding in patients with CRC was low and similar in both apixaban and LMWH groups Patients with CRC are underrepresented in the major trials examining treatment of CAT with anticoagulant Despite concerns that DOACs pose a significant bleeding risk in CRC patients many patients with CRC are treated with apixaban or rivaroxaban in clinical practice Balancing risks of thrombosis recurrence and bleeding can be challenging and requires a nuanced individualized approach to decision making to improve prognosis in this population The aim of this study is to identify risk factors for recurrence and bleeding in CRC patients with VTE Deaths regardless of the mechanism will also be included in the one year all-cause mortality outcome
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?:
False
Is an FDA AA801 Violation?:
None