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NCT03006341 · ClinicalTrials.gov registry record

Validation of Predictors of OAC Initiation Using EMR Data

A clinical trial, sponsored by Boehringer Ingelheim.

Completed
Registry status
140,187
Enrollment target

NCT03006341: Completed study, sponsored by Boehringer Ingelheim.

NCT03006341 is a clinical trial that has completed, run by Boehringer Ingelheim. The registered enrollment target is 140,187 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03006341 has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
140,187 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • DRUG Warfarin
  • DRUG Dabigatran etexilate

Trial Details

FieldValue
Enrollment Target 140,187 participants
Start Date 2017-02-28
Est. Completion 2017-05-09
Boehringer Ingelheim

515 total trials

What the finished NCT03006341 record still lists

NCT03006341 is an observational study that tracks outcomes without assigning an intervention. Its 140,187 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.

NCT03006341 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03006341 about?

NCT03006341 is a clinical study titled "Validation of Predictors of OAC Initiation Using EMR Data". 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; secon...

What is the current status of trial NCT03006341?

This trial is currently completed. The enrollment target is 140,187 participants. The study started on 2017-02-28. Estimated completion is 2017-05-09.

What interventions are being tested in trial NCT03006341?

The interventions under investigation include: Warfarin (DRUG), Dabigatran etexilate (DRUG).

Who is sponsoring clinical trial NCT03006341?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03006341, the US trial registry maintained by the National Library of Medicine. NCT03006341 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.