N/A
N=873
ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04532528 ↗Enrolled (actual)
873
Serious AEs
1.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention — 199; 181 Participants — p=0.9701
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dabigatran (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention |
199; 181 | 0.9701 |
| SECONDARY Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention |
224; 229; 199; 218; 204; 184 | 0.7376 |
| SECONDARY Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention |
83; 77; 66; 57; 52; 53 | 0.5777 |
| SECONDARY Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention |
56; 58; 35; 28; 28; 25 | 0.8509 |
| SECONDARY Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention |
7.0; 7.0; 7.2; 7.3; 7.4; 7.3 | 0.6670 |
| SECONDARY Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention |
167; 181; 225; 213; 48; 37 | — |
| SECONDARY Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention |
60; 70; 107; 111 | — |
| SECONDARY Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention |
12; 13; 3; 3; 1; 0 | — |
Summary
Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy.
The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.
Eligibility Criteria
Inclusion Criteria
Patients can be included if ALL the following criteria are met:
- Provide written informed consent prior to participation
- Female or male adult patients aged ≥ 20 years and < 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment.
Exclusion Criteria
Patients should not be included if ANY ONE of the following criteria is met:
- Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran [e.g., anaphylactic reaction or anaphylactic shock], severely impaired renal function [Creatinine clearance rate (Ccr) < 30 mL/min], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole)
- Participate in other interventional trials currently or in the past 30 days
Data sourced from ClinicalTrials.gov (NCT04532528). 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.