Validation of Predictors of OAC Initiation Using EMR Data

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03006341

Run by

Boehringer Ingelheim

People needed

140187

Starts

2017-02-28

Expected to finish

2017-05-09

Last updated by the study team

2019-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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