Clinical trial NCT03006341: Validation of Predictors of OAC Initiation Using EMR Data
Official title: Validation of Predictors for Oral Anticoagulant Medication Choice Using EMR Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-12-30
Enrollment: 140187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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.


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

Primary outcomes:
measure: Percentage of Patients With Obesity
timeFrame: Up to 12 months
measure: Percentage of Patients Smoking
timeFrame: Up to 12 months
measure: Percentage of Patients With Alcohol Consumption
timeFrame: Up to 12 months
measure: Percentage of Patients With Abnormal Renal Function
timeFrame: Up to 12 months
measure: Percentage of Patients With Bleeding History or Predisposition
timeFrame: Up to 12 months
measure: EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)
timeFrame: Up to 12 months
measure: EMR Characteristic: Serum Creatinine
timeFrame: Up to 12 months
measure: Percentage of Patients With Abnormal Liver Function
timeFrame: Up to 12 months
Secondary outcomes:
measure: EMR Characteristic: Duration of Atrial Fibrillation
timeFrame: Up to 12 months
measure: EMR Characteristic: History of Adherence: Non-adherent/Adherent
timeFrame: Up to 12 months
measure: EMR Characteristic: History/Duration of Hypertension
timeFrame: Up to 12 months
measure: Percentage of Patients With Uncontrolled Hypertension
timeFrame: Up to 12 months
measure: EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)
timeFrame: Up to 12 months
measure: Percentage of Patients With Prior Transient Ischemic Attack
timeFrame: Up to 12 months
measure: Percentage of Patients With Diabetes
timeFrame: Up to 12 months
measure: Percentage of Patients With Hyperlipidemia
timeFrame: Up to 12 months
measure: EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score
timeFrame: Up to 12 months
measure: Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
References: