N/A
Completed N=140,187
Validation of Predictors of OAC Initiation Using EMR Data
Source: ClinicalTrials.gov NCT03006341 ↗Enrolled (actual)
140,187
Serious AEs
—
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Patients With Obesity — 58.2; 51.7; 57.4; 54.2 Percentage of patients
Summary
The objectives of this study are, first, to identify select clinical covariates from electronic medical records (EMR) that might be associated with initiation of oral anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial fibrillation (NVAF) at risk for stroke; second, to quantify the association between EMR-based clinical characteristics and patterns of insurance claims; third, to assess the potential for unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies based on administrative claims databases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Obesity |
58.2; 51.7; 57.4; 54.2 | — |
| PRIMARY Percentage of Patients Smoking |
50.0; 51.8; 50.0; 50.5 | — |
| PRIMARY Percentage of Patients With Alcohol Consumption |
47.1; 50.9; 50.0; 38.9 | — |
| PRIMARY Percentage of Patients With Abnormal Renal Function |
5.5; 11.7; 6.5; 8.0 | — |
| PRIMARY Percentage of Patients With Bleeding History or Predisposition |
3.4; 4.7; 3.7; 4.6 | — |
| PRIMARY EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR) |
86.5; 78.3; 85.4; 83.4 | — |
| PRIMARY EMR Characteristic: Serum Creatinine |
1.0; 1.1; 1.0; 1.0 | — |
| PRIMARY Percentage of Patients With Abnormal Liver Function |
0.5; 0.7; 0.5; 0.0 | — |
| SECONDARY EMR Characteristic: Duration of Atrial Fibrillation |
22.5; 26.4; 22.7; 25.4 | — |
| SECONDARY EMR Characteristic: History of Adherence: Non-adherent/Adherent |
— | — |
| SECONDARY EMR Characteristic: History/Duration of Hypertension |
42.4; 43.8; 43.6; 40.9 | — |
| SECONDARY Percentage of Patients With Uncontrolled Hypertension |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY EMR Characteristic: History/Duration of Congestive Heart Failure (CHF) |
28.2; 38.3; 26.0; 33.9 | — |
| SECONDARY Percentage of Patients With Prior Transient Ischemic Attack |
1.6; 2.1; 1.4; 2.4 | — |
| SECONDARY Percentage of Patients With Diabetes |
13.4; 18.2; 14.7; 14.5 | — |
| SECONDARY Percentage of Patients With Hyperlipidemia |
34.8; 36.8; 35.6; 34.0 | — |
| SECONDARY EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score |
1.4; 1.6; 1.5; 1.5 | — |
| SECONDARY Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs |
18.0; 18.4; 17.1; 18.7 | — |
Eligibility Criteria
Inclusion Criteria
- First dispensing of warfarin or dabigatran between October 2010 and December 2014
- Diagnosis of atrial fibrillation
- ≥ 12 months enrolment in the database preceding the date of the first dispensing
- Age ≥ 18
- Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease (CHA2DS2-VASc) score ≥ 1
Exclusion Criteria
- Prior use of oral anticoagulation
- Evidence of valvular atrial fibrillation
- Missing or ambiguous age or sex information
- Patients with a nursing home stay during baseline
Data sourced from ClinicalTrials.gov (NCT03006341). 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.