Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865978
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2021-04-26
Brief Title:
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Sponsor:
Palak Shah
Organization:
Inova Health Care Services
Study Overview
Official Title:
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
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:
DOAC LVAD
Brief Summary:
Prospective randomized controlled open label trial of LVAD patients with 11 randomization to either apixaban or warfarin
Detailed Description:
This pilot study will be a prospective randomized controlled open label trial of HeartMate 3 HM3 LVAD patients with 11 randomization to either apixaban or warfarin All patients will be treated with aspirin 81 mg daily as per the LVAD manufacturer instructions for use IFU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None