Validation of Predictors of OAC Initiation Using EMR Data

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Dabigatran etexilate; Drug: Warfarin

Study type: Observational

Funder types: Industry

Identifiers

NCT03006341

1160-0219

Details and patient eligibility

About

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.

Enrollment: 140,187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

140,187 participants in 2 patient groups

Dabigatran etexilate

Description:

NVAF patients initiating dabigatran etexilate

Treatment:

Drug: Dabigatran etexilate

Warfarin

Description:

NVAF patients initiating warfarin

Treatment:

Drug: Warfarin