18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients With ObesityPrimary· Up to 12 months
Percentage of patients with obesity; where obesity is defined as "obese, not-obese based on note of obesity or recorded body mass index (BMI) \> 30 in the electronic medical records (EMR)". The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
58.2
Warfarin
51.7
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
57.4
Warfarin
54.2
Percentage of Patients SmokingPrimary· Up to 12 months
Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
50.0
Warfarin
51.8
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
50.0
Warfarin
50.5
Percentage of Patients With Alcohol ConsumptionPrimary· Up to 12 months
Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
47.1
Warfarin
50.9
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
50.0
Warfarin
38.9
Percentage of Patients With Abnormal Renal FunctionPrimary· Up to 12 months
Percentage of patients with abnormal renal function; defined as "Any note of: Dialysis, renal transplant Serum Creatinine \>1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR)". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, w
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
5.5
Warfarin
11.7
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
6.5
Warfarin
8.0
Percentage of Patients With Bleeding History or PredispositionPrimary· Up to 12 months
Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of \> 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusi
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
3.4
Warfarin
4.7
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
3.7
Warfarin
4.6
EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)Primary· Up to 12 months
EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
86.5
± 21.6
Warfarin
78.3
± 25.1
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
85.4
± 21.9
Warfarin
83.4
± 23.5
EMR Characteristic: Serum CreatininePrimary· Up to 12 months
EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
1.0
± 0.3
Warfarin
1.1
± 0.6
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
1.0
± 0.3
Warfarin
1.0
± 0.4
Percentage of Patients With Abnormal Liver FunctionPrimary· Up to 12 months
Percentage of patients with abnormal liver function; defined as "Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) \>3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
0.5
Warfarin
0.7
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
0.5
Warfarin
0.0
EMR Characteristic: Duration of Atrial FibrillationSecondary· Up to 12 months
EMR characteristic: Duration of atrial fibrillation (Years / months prior to initiation of Dabigatran / Warfarin). Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
22.5
± 33.8
Warfarin
26.4
± 32.5
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
22.7
± 35.2
Warfarin
25.4
± 33.0
EMR Characteristic: History/Duration of HypertensionSecondary· Up to 12 months
EMR characteristic: History/duration of hypertension. Any note of: Hypertension systolic blood pressure (SBP) \>120 millimeters of mercury (mmHg) Hypertension drugs. Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
42.4
± 42.8
Warfarin
43.8
± 41.5
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
43.6
± 43.7
Warfarin
40.9
± 40.6
Percentage of Patients With Uncontrolled HypertensionSecondary· Up to 12 months
Percentage of patients with uncontrolled hypertension; defined as "SBP \>160 mmHg using the most recent information prior to index date in the electronic medical records (EMR)". The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
0.0
Warfarin
0.0
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
0.0
Warfarin
0.0
EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)Secondary· Up to 12 months
EMR characteristic: History/duration of Congestive Heart Failure (CHF). Duration is defined as number of months prior to index date for the earliest note. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Before PS matching
Group
Value
95% CI
Dabigatran Etexilate
28.2
± 30.8
Warfarin
38.3
± 38.6
After PS matching
Group
Value
95% CI
Dabigatran Etexilate
26.0
± 30.1
Warfarin
33.9
± 38.0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 22 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03006341.