Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474182
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-23
Brief Title:
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Comparison of the Effects of Prophylactic Administration of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma and Patients Undergoing a Surgery for Total Knee Replacement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
ProApix
Brief Summary:
Patients with multiple myeloma MM are at high risk of venous thromboembolism VTE and these patients require adequate thromboprophylaxis Following the publication of the AVERT clinical study Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer based on high quality of evidence and a favorable efficacysafety profile A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted The peak drug concentration was superior in MM plasma as compared to non-myeloma patients under prophylaxis Therefore the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics ie decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis In fine this study may inform to better manage thromboprophylaxis in MM patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANSM | OTHER | None | None |