N/A
Completed N=63
Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial
Source: ClinicalTrials.gov NCT05085405 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 — 7; 12; 8; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 |
7; 12; 8; 8 | — |
| SECONDARY Feasibility of Delivering Intervention Components as Intended |
13; 13; 11; 10 | — |
Eligibility Criteria
Inclusion Criteria for Patients:
- Enrollment with the Michigan Medicine anticoagulation monitoring service
- Currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
- Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list
Exclusion Criteria for Patients:
- Prescribed a Proton Pump Inhibitor (PPI)
- Documented intolerance or allergy to PPI use
- Left ventricular assist device
- Heart transplant
Inclusion Criteria for Clinicians:
- Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
- Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria
Exclusion Criteria for Clinicians:
- Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.
Data sourced from ClinicalTrials.gov (NCT05085405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.