N/A
N=25,586
The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02043808 ↗Enrolled (actual)
25,586
Serious AEs
—
Results posted
Jul 2015
Primary outcome: Primary: Stroke (Hemorrhagic, Ischemic) — 9.15; 13.19 Events per 1000 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroke (Hemorrhagic, Ischemic) |
9.15; 13.19 | — |
| PRIMARY Major Bleeding |
30.84; 37.04 | — |
| SECONDARY Ischemic Stroke |
8.48; 10.69 | — |
| SECONDARY Hemorrhagic Stroke |
0.77; 2.50 | — |
| SECONDARY Major Intracranial Bleeding |
2.69; 5.65 | — |
| SECONDARY Major Extracranial Bleeding |
28.13; 31.30 | — |
| SECONDARY Major GI Bleeding |
25.40; 23.69 | — |
| SECONDARY Major Upper GI Bleeding |
5.48; 7.63 | — |
| SECONDARY Major Lower GI Bleeding |
20.25; 16.38 | — |
| SECONDARY Major Urogenital Bleeding |
1.06; 3.02 | — |
| SECONDARY Major Other Bleeding |
1.92; 5.13 | — |
| SECONDARY Transient Ischemic Attack |
4.62; 5.53 | — |
| SECONDARY Myocardial Infarction |
5.09; 7.77 | — |
| SECONDARY Venous Thromboembolism |
1.34; 2.10 | — |
| SECONDARY Deep Vein Thrombosis |
0.58; 1.31 | — |
| SECONDARY Pulmonary Embolism |
0.77; 0.79 | — |
| SECONDARY Death |
31.28; 52.41 | — |
Summary
The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.
Eligibility Criteria
Inclusion criteria
- Patients must be continuously enrolled in a health plan during the pre-index period;
- Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
- Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
- Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
- Aged 18-89 on the index date;
Exclusion criteria
- Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
- Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;
Data sourced from ClinicalTrials.gov (NCT02043808). 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.