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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: November 25, 2013
Last updated: October 27, 2015
Last verified: October 2015
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.

Atrial Fibrillation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Frequencies of patients with index event safety outcomes (ongoing/resolved/deceased) [ Time Frame: at time of discharge ] [ Designated as safety issue: No ]
  • Frequencies of patients receiving different type of interventions to stop the index event [ Time Frame: until discharge ] [ Designated as safety issue: No ]
  • Frequencies of bleeding types and anatomic locations of the index event [ Time Frame: at time of presentation ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: January 2014
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Detailed Description:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02022020

  Show 23 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT02022020     History of Changes
Other Study ID Numbers: 1160.162 
Study First Received: November 25, 2013
Last Updated: October 27, 2015
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on January 14, 2017