N/A
Completed N=22,490
Comparative Effectiveness and Safety Between Warfarin and Dabigatran
Source: ClinicalTrials.gov NCT03254134 ↗Enrolled (actual)
22,490
Serious AEs
—
Results posted
Jul 2019
Primary outcomePrimary: Incidence Rate of Stroke and Systemic Embolism (SE) — 2.898; 3.563 per patient-year
Summary
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Stroke and Systemic Embolism (SE) |
2.898; 3.563 | — |
| SECONDARY Incidence Rate of Major Bleeding |
0.639; 1.128 | — |
Eligibility Criteria
Inclusion Criteria
- patients aged >18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)
- having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016
- having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)
Exclusion Criteria
- patients having less than 12 months of enrolment prior to the index date
- being dialysis or kidney transplant recipients in baseline period
- having either atrial flutter, valvular atrial fibrillation (AF)
- mechanical valve placement, rheumatic AF
- and/or mitral valve prolapse/regurge/stenosis in baseline period
- having record of deep vein thrombosis or pulmonary embolism < 6 months before AF diagnosis in baseline period
Data sourced from ClinicalTrials.gov (NCT03254134). 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.