CClinicalTrials.gg
CompletedNCT03006341Updated Mar 22, 2019Results posted

Validation of Predictors of OAC Initiation Using EMR Data

An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-22.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
140,187
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

Browse trials for

03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 140,187 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a recorded diagnosis of atrial fibrillation without evidence of valvular etiology and at risk for stroke

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
140,187 participants (actual)
Patient registry
No

Groups and cohorts

  • Dabigatran etexilate

    NVAF patients initiating dabigatran etexilate

    Drug: Dabigatran etexilate

  • Warfarin

    NVAF patients initiating warfarin

    Drug: Warfarin

Interventions

  • DrugDabigatran etexilate

    observed upto 12 months

    Also known as: MICARDIS, PRITOR, TELMISARTAN

  • DrugWarfarin

    Observed upto 12 months

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With Obesity

    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.

    Time frame: Up to 12 months

  2. Percentage of Patients Smoking

    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.

    Time frame: Up to 12 months

  3. Percentage of Patients With Alcohol Consumption

    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.

    Time frame: Up to 12 months

  4. Percentage of Patients With Abnormal Renal Function

    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, whose data were available.

    Time frame: Up to 12 months

  5. Percentage of Patients With Bleeding History or Predisposition

    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/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

    Time frame: Up to 12 months

  6. EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)

    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.

    Time frame: Up to 12 months

  7. EMR Characteristic: Serum Creatinine

    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.

    Time frame: Up to 12 months

  8. Percentage of Patients With Abnormal Liver Function

    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 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.

    Time frame: Up to 12 months

Secondary outcomes

  1. EMR Characteristic: Duration of Atrial Fibrillation

    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.

    Time frame: Up to 12 months

  2. EMR Characteristic: History of Adherence: Non-adherent/Adherent

    EMR characteristic: History of adherence: non-adherent/adherent.

    Time frame: Up to 12 months

  3. EMR Characteristic: History/Duration of Hypertension

    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.

    Time frame: Up to 12 months

  4. Percentage of Patients With Uncontrolled Hypertension

    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.

    Time frame: Up to 12 months

  5. EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)

    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.

    Time frame: Up to 12 months

  6. Percentage of Patients With Prior Transient Ischemic Attack

    Percentage of patients with any note of prior transient ischemic attack 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, whose data were available.

    Time frame: Up to 12 months

  7. Percentage of Patients With Diabetes

    Percentage of patients with any note of diabetes type I or II in the electronic medical records (EMR) is presented. 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.

    Time frame: Up to 12 months

  8. Percentage of Patients With Hyperlipidemia

    Percentage of patients with hyperlipidemia is presented, defined as any note of hyperlipidemia, dyslipidemia or Low Density Lipoprotein (LDL) \>130 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, whose data were available.

    Time frame: Up to 12 months

  9. EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score

    EMR characteristic: HAS-BLED Score. HAS-BLED score is calculated by adding the specified points for each of the conditions listed below. Hypertension (uncontrolled), Abnormal renal and liver function, Stroke, Bleeding history or predisposition (anemia), Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol (1 point each). Labile INR is defined as as the most recent INR \<2 or \>3 prior to cohort entry. Conditions are 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.

    Time frame: Up to 12 months

  10. Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs

    Percentage of patients with use of antiplatelets or non-steroidal anti-inflammatory drugs (NSAIDs). Includes use of aspirin, clopidogrel, prasugrel, ticagrelor or NSAIDs (within 1 month or on the index date) 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, whose data were available.

    Time frame: Up to 1 month

07

Results

Posted Mar 22, 2019

Participant flow

A validation study; Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran or warfarin between October 2010 and December 2014.

Participant flow — Overall Study
MilestoneDabigatran EtexilateWarfarinRivaroxabanApixaban
Started26199700713259511322
Completed113025661602637
Not completed25069675053099310685
Withdrew: Not linked in the emr25069675053099310685

Outcome measures

PrimaryPercentage of Patients With Obesity

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.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Obesity
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching58.251.7
After PS matching57.454.2
PrimaryPercentage of Patients Smoking

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.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients Smoking
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching50.051.8
After PS matching50.050.5
PrimaryPercentage of Patients With Alcohol Consumption

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.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Alcohol Consumption
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching47.150.9
After PS matching50.038.9
PrimaryPercentage of Patients With Abnormal Renal Function

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, whose data were available.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Abnormal Renal Function
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching5.511.7
After PS matching6.58.0
PrimaryPercentage of Patients With Bleeding History or Predisposition

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/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Bleeding History or Predisposition
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching3.44.7
After PS matching3.74.6
Statistical analysis
  • Dabigatran Etexilate vs Warfarin · Regression, Logistic · C-statistic: 0.81The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.
PrimaryEMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)

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.

Time frame:
Up to 12 months
Reported as:
Mean · Milliliter/minute/1.73 square meter
EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)
Milliliter/minute/1.73 square meterDabigatran EtexilateWarfarin
Before PS matching86.5 ± 21.678.3 ± 25.1
After PS matching85.4 ± 21.983.4 ± 23.5
PrimaryEMR Characteristic: Serum Creatinine

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.

Time frame:
Up to 12 months
Reported as:
Mean · Milligrams per deciliter
EMR Characteristic: Serum Creatinine
Milligrams per deciliterDabigatran EtexilateWarfarin
Before PS matching1.0 ± 0.31.1 ± 0.6
After PS matching1.0 ± 0.31.0 ± 0.4
Statistical analysis
  • Dabigatran Etexilate vs Warfarin · Regression, Linear · Adjusted r squared statistic: 0.02The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.
PrimaryPercentage of Patients With Abnormal Liver Function

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 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.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Abnormal Liver Function
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching0.50.7
After PS matching0.50.0
SecondaryEMR Characteristic: Duration of Atrial Fibrillation

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.

Time frame:
Up to 12 months
Reported as:
Mean · Months
EMR Characteristic: Duration of Atrial Fibrillation
MonthsDabigatran EtexilateWarfarin
Before PS matching22.5 ± 33.826.4 ± 32.5
After PS matching22.7 ± 35.225.4 ± 33.0
Statistical analysis
  • Dabigatran Etexilate vs Warfarin · Regression, Linear · Adjusted r squared statistic: 0.04The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.
SecondaryEMR Characteristic: History of Adherence: Non-adherent/Adherent

EMR characteristic: History of adherence: non-adherent/adherent.

Time frame:
Up to 12 months

No measurements were reported for this outcome.

SecondaryEMR Characteristic: History/Duration of Hypertension

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.

Time frame:
Up to 12 months
Reported as:
Mean · Months
EMR Characteristic: History/Duration of Hypertension
MonthsDabigatran EtexilateWarfarin
Before PS matching42.4 ± 42.843.8 ± 41.5
After PS matching43.6 ± 43.740.9 ± 40.6
SecondaryPercentage of Patients With Uncontrolled Hypertension

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.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Uncontrolled Hypertension
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching0.00.0
After PS matching0.00.0
SecondaryEMR Characteristic: History/Duration of Congestive Heart Failure (CHF)

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.

Time frame:
Up to 12 months
Reported as:
Mean · Months
EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)
MonthsDabigatran EtexilateWarfarin
Before PS matching28.2 ± 30.838.3 ± 38.6
After PS matching26.0 ± 30.133.9 ± 38.0
SecondaryPercentage of Patients With Prior Transient Ischemic Attack

Percentage of patients with any note of prior transient ischemic attack 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, whose data were available.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Prior Transient Ischemic Attack
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching1.62.1
After PS matching1.42.4
SecondaryPercentage of Patients With Diabetes

Percentage of patients with any note of diabetes type I or II in the electronic medical records (EMR) is presented. 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.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Diabetes
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching13.418.2
After PS matching14.714.5
Statistical analysis
  • Dabigatran Etexilate vs Warfarin · Regression, Logistic · C-statistic: 0.88The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.
SecondaryPercentage of Patients With Hyperlipidemia

Percentage of patients with hyperlipidemia is presented, defined as any note of hyperlipidemia, dyslipidemia or Low Density Lipoprotein (LDL) \>130 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, whose data were available.

Time frame:
Up to 12 months
Reported as:
Number · Percentage of patients
Percentage of Patients With Hyperlipidemia
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching34.836.8
After PS matching35.634.0
Statistical analysis
  • Dabigatran Etexilate vs Warfarin · Regression, Logistic · C-statistic: 0.69The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.
SecondaryEMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score

EMR characteristic: HAS-BLED Score. HAS-BLED score is calculated by adding the specified points for each of the conditions listed below. Hypertension (uncontrolled), Abnormal renal and liver function, Stroke, Bleeding history or predisposition (anemia), Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol (1 point each). Labile INR is defined as as the most recent INR \<2 or \>3 prior to cohort entry. Conditions are 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.

Time frame:
Up to 12 months
Reported as:
Mean · Unit on Scale
EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score
Unit on ScaleDabigatran EtexilateWarfarin
Before PS matching1.4 ± 1.01.6 ± 1.0
After PS matching1.5 ± 1.01.5 ± 1.0
Statistical analysis
  • Dabigatran Etexilate vs Warfarin · Regression, Linear · Adjusted r squared statistic: 0.34The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.
SecondaryPercentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs

Percentage of patients with use of antiplatelets or non-steroidal anti-inflammatory drugs (NSAIDs). Includes use of aspirin, clopidogrel, prasugrel, ticagrelor or NSAIDs (within 1 month or on the index date) 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, whose data were available.

Time frame:
Up to 1 month
Reported as:
Number · Percentage of patients
Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs
Percentage of patientsDabigatran EtexilateWarfarin
Before PS matching18.018.4
After PS matching17.118.7

Adverse events

Collected over Safety monitoring and safety reporting on an individual case level is not applicable.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dabigatran Etexilate———
Warfarin———
Rivaroxaban———
Apixaban———

Baseline characteristics

Baseline characteristics are based on all patients who successfully linked in the EMR

Age, Continuous
Age, Continuous(Years)Dabigatran EtexilateWarfarinRivaroxabanApixabanTotal
Mean65.1 ± 11.469.3 ± 11.366.2 ± 11.167.3 ± 11.467.4 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)Dabigatran EtexilateWarfarinRivaroxabanApixabanTotal
Female43210066002502288
Male698156010023873647
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Dabigatran EtexilateWarfarinRivaroxabanApixabanTotal
Count of participants————0
08

Study locations

1 site
  • Brigham & Women's Hospital
    Boston, Massachusetts 02120, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 2, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03006341
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Dec 30, 2016
Start date
Feb 28, 2017
Primary completion
May 9, 2017
Completion
May 9, 2017
Results posted
Mar 22, 2019
Last update
Mar 22, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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