Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05085405
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2021-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pilot Trial to Evaluate Clinician- and Patient-facing Strategies to Reduce Upper Gastrointestinal Bleeding Risk in Patients on Combination Antithrombotic Therapy
Status:
COMPLETED
Status Verified Date:
2023-06
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:
AEGIS
Brief Summary:
This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.
Detailed Description:
In February 2022, the IRB approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. As no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. However, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.
Study Oversight
Has Oversight DMC:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DK118179 | NIH | None | https://reporter.nih.gov/quic… | View |