Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 1:54 PM
Study NCT ID:
NCT01897103
Status:
COMPLETED
Last Update Posted:
2017-12-14
First Post:
2013-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Activity in Vascular Surgery for Thrombosis and Bleeding
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Platelet Activity in Vascular Surgery
Status:
COMPLETED
Status Verified Date:
2017-12
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:
PIVOTAL
Brief Summary:
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.
Detailed Description:
To describe platelet activity among PAD subjects undergoing vascular surgery.
To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.
To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.
To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
Study Oversight
Has Oversight DMC:
False
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?: