Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-02 @ 8:38 PM
Study NCT ID:
NCT02966002
Status:
TERMINATED
Last Update Posted:
2018-05-18
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to inability to recruit sufficient patients.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: