Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa

NCT ID: NCT02022020

Last Updated: 2017-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

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This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

Detailed Description

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Purpose:

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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Group 1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* \>=18 years of age;
* Confirmed diagnosis of Atrial Fibrillation (AF);
* Documentation that the patient had an acute GI and/or GU bleeding event and having taken at least one dose of dabigatran prior to the event.

Exclusion Criteria

* Confirmed diagnosis of valvular AF (VAF);
* Documentation that the patient was taking dabigatran with other oral anticoagulant;
* Documentation of the patient receiving thrombolytic therapy prior to the event;
* Documentation that the patient was enrolled in an investigational clinical trial at the time of the event;
* Medical record was not available.
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

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

New Britain, Connecticut, United States

Site Status

Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

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Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

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Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Site Status

Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

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Boehringer Ingelheim Investigational Site

Hackensack, New Jersey, United States

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Boehringer Ingelheim Investigational Site

New York, New York, United States

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Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

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Boehringer Ingelheim Investigational Site

Philedelphia, Pennsylvania, United States

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Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

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Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

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Boehringer Ingelheim Investigational Site

Roanoke, Virginia, United States

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Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

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Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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1160.162

Identifier Type: -

Identifier Source: org_study_id

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