Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT03111420
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2017-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of AggreGuide A-100 (ADP) Assay
Sponsor:
Aggredyne, Inc.
Organization:
Study Overview
Official Title:
Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.
Detailed Description:
Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: