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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02022020
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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.

Condition or disease
Atrial Fibrillation

Detailed Description:
Purpose:
Study Design
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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Study Assessing the Management of Gastrointestinal and Urogenital Bleeding Events in Patients With Atrial Fibrillation Treated With Dabigatran Etexilate
Study Start Date : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Group 1


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge [ Time Frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days. ]

    Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.

    Emergency Department/Room (ED/ER).

    Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:

    • Ongoing, if symptoms of bleeding not completely resolved at time of discharge;
    • Deceased in case of death;
    • Resolved otherwise.

  2. Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge [ Time Frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. ]
    Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.

  3. Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation [ Time Frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. ]
    Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
AF patients with bleeding event using Dabigatran etexilate
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022020


Locations
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United States, Colorado
Boehringer Ingelheim Investigational Site
Aurora, Colorado, United States
United States, Connecticut
Boehringer Ingelheim Investigational Site
New Britain, Connecticut, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Louisiana
Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Massachusetts
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Missouri
Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, New Jersey
Boehringer Ingelheim Investigational Site
Hackensack, New Jersey, United States
United States, New York
Boehringer Ingelheim Investigational Site
New York, New York, United States
Boehringer Ingelheim Investigational Site
Staten Island, New York, United States
United States, Pennsylvania
Boehringer Ingelheim Investigational Site
Philedelphia, Pennsylvania, United States
United States, Tennessee
Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
United States, Virginia
Boehringer Ingelheim Investigational Site
Charlottesville, Virginia, United States
Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
Boehringer Ingelheim Investigational Site
Roanoke, Virginia, United States
Canada, Alberta
Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Canada, British Columbia
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, New Brunswick
Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
Canada, Nova Scotia
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
Canada, Quebec
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02022020    
Other Study ID Numbers: 1160.162
First Posted: December 27, 2013    Key Record Dates
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes