N/A
Completed N=48,646
Treatment Pattern of Oral Anticoagulants (OAC) in Japan
Source: ClinicalTrials.gov NCT02982863 ↗Enrolled (actual)
48,646
Serious AEs
—
Results posted
Sep 2018
Primary outcomePrimary: Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF — 4936; 12484; 11386; 8758 Participants
Summary
1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
2. To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF |
4936; 12484; 11386; 8758; 2268 | — |
| PRIMARY Number of Patients Prescribed OAC Drug Dabigatran by Dosage |
58; 164; 354; 3343; 5; 1072 | — |
| PRIMARY Number of Patients Prescribed OAC Drug Warfarin by Dosage |
2; 1; 3; 4; 338; 2 | — |
| PRIMARY Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage |
14; 3; 3; 2; 4372; 4 | — |
| PRIMARY Number of Patients Prescribed OAC Drug Apixaban by Dosage |
2; 428; 2; 6300; 1; 4789 | — |
| PRIMARY Number of Patients Prescribed OAC Drug Edoxaban by Dosage |
279; 1594; 412 | — |
| SECONDARY Baseline Characteristics: Age |
72; 78; 77; 74; 77 | — |
| SECONDARY Baseline Characteristics: Gender |
1625; 5068; 4737; 3183; 1130; 3311 | — |
| SECONDARY Baseline Characteristics: Year of Initiating Treatment |
404; 1138; 0; 0; 8; 1259 | — |
| SECONDARY Baseline Characteristics: Speciality of Prescribers of OAC |
1689; 4316; 3943; 2816; 654; 2 | — |
| SECONDARY Baseline Characteristics: History of Disease |
63; 145; 128; 85; 21; 317 | — |
| SECONDARY Baseline Characteristics: History of Hospitalization |
2384; 9494; 6517; 4589; 1412 | — |
| SECONDARY Baseline Characteristics: AF Risk Score |
707; 750; 1150; 1072; 238; 1103 | — |
| SECONDARY Baseline Characteristics: Concomitant Medication |
989; 2848; 2027; 1621; 377; 69 | — |
Eligibility Criteria
Inclusion criteria
- Patients aged >18 year-old with confirmed diagnosis of NVAF (ICD 10 code I48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other OACs for12 months prior to the index date (defined as the first prescription of OACs (the period is defined as baseline period)), and having an index date between 14 Mar 2011 to 30 June 2016
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 AF, mechanical valve placement, rheumatic AF, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism < 6 months before Atrial Fibrillation (AF) diagnosis in baseline period
Data sourced from ClinicalTrials.gov (NCT02982863). 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.