Validation of Predictors of OAC Initiation Using EMR Data

NCT ID: NCT03006341

Last Updated: 2019-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2017-05-09

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dabigatran etexilate

NVAF patients initiating dabigatran etexilate

Dabigatran etexilate

Intervention Type DRUG

observed upto 12 months

Warfarin

NVAF patients initiating warfarin

Warfarin

Intervention Type DRUG

Observed upto 12 months

Interventions

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Dabigatran etexilate

observed upto 12 months

Intervention Type DRUG

Warfarin

Observed upto 12 months

Intervention Type DRUG

Other Intervention Names

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MICARDIS, PRITOR, TELMISARTAN

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1160-0219

Identifier Type: -

Identifier Source: org_study_id

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