N/A
Completed N=341
Anticoagulation With Enhanced Gastrointestinal Safety
Upper Gastrointestinal Bleeding · Peptic Ulcer Hemorrhage · Anticoagulant-induced Bleeding
Source: ClinicalTrials.gov NCT05563714 ↗
Enrolled (actual)
341
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: ITT Analysis - Percent of Patients Reporting Medication Optimization — 30; 2; 29; 65 Participants — p=<0.001
Summary
This study is a pragmatic cluster randomized controlled trial to evaluate the effectiveness of a clinician-facing implementation strategy on the use of medication optimization (defined as either discontinuation of all antiplatelet therapy or initiation of and adherence to a proton pump inhibitor (PPI)) to reduce upper GI bleeding risk in patients prescribed anticoagulant-antiplatelet therapy (AAT) relative to usual care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ITT Analysis - Percent of Patients Reporting Medication Optimization |
30; 2; 29; 65; 15; 10 | <0.001 sig |
| PRIMARY Modified Completer Analysis - Percent of Patients Reporting Medication Optimization |
30; 2; 17; 1; 11; 1 | <0.001 sig |
| SECONDARY ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation |
75; 1; 32; 1; 38; 0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria for Patients:
- Enrollment with the Michigan Medicine anticoagulation monitoring service
- Currently prescribed warfarin with anticipated use for ≥90 days on day 1 of trial enrollment, according to the electronic health record documentation.
- Currently prescribed an antiplatelet medication (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic health record medication list
Inclusion Criteria for Clinicians:
- Cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria
- Michigan Medicine primary care providers for patients who meet eligibility criteria
- 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 Patients:
- Age less than 18
- Currently prescribed a PPI
- Documented intolerance or allergy to PPI use
- Left ventricular assist device
- Heart transplant
- Participation in a previous pilot study of these implementation strategies
Exclusion Criteria for Clinicians:
- Cardiologists specializing in electrophysiology or who saw the patient for a clinic visit related to a TAVI procedure unless they are the clinician of record for a patient followed by the anticoagulation service who does not have a Michigan Medicine PCP.
- Participation in a previous pilot study of these QI strategies
Data sourced from ClinicalTrials.gov (NCT05563714). 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.