Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 1:16 PM
Study NCT ID:
NCT04191928
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
An Exploratory Study of the Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy
Status:
COMPLETED
Status Verified Date:
2021-12
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:
PAP-UP
Brief Summary:
Study investigators will examine the absorption characteristics of apixaban, a direct-acting oral anticoagulation, in patients who have underwent a particular kind of surgery (pancreaticoduodenectomy) which involves resection of the duodenum.
Detailed Description:
This study will examine apixaban pharmacokinetic exposure (AUC(0-24)) and maximum concentration (Cmax) when administered as a single oral dose in patients who have undergone pancreaticoduodenectomy (PD) compared to historical controls. This is a phase one, single dose pharmacokinetic study in stable patients who have undergone pancreaticoduodenectomy. Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. This study aims to compare the pharmacokinetics and absorption of oral apixaban in patients who have undergone pancreaticoduodenectomy to that of apixaban in historical controls.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: