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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: November 25, 2013
Last updated: July 1, 2015
Last verified: July 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: up to Day 1095 ] [ Designated as safety issue: No ]
    Frequency of patients with the index bleeding event ongoing at the time of hospital discharge; Frequency of patients with the index bleeding event resolved at the time of hospital discharge; Frequency of patients with the index bleeding event who deceased druing hospital stay;

  • Frequencies of patients receiving different type of interventions to stop the index event [ Time Frame: up to Day 1095 ] [ Designated as safety issue: No ]
    Treatment includes any of the following: medications, surgery, therapeutic procedures, transfusions/infusions, hemodialysis, hemofiltration, and discontinuation of dabigatran etexilate

  • Frequencies of bleeding types (Gastrointestinal, Urogenital) and anatomical locations (Pharynx, Esophagus, Stomach, Duodenum, Small Intestine, Large Intestine, Rectum, Kidney, Ureter, Bladder, Prostate, Uterine) of the index bleeding event [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Detailed Description:



Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

  Show 30 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT02022020     History of Changes
Other Study ID Numbers: 1160.162
Study First Received: November 25, 2013
Last Updated: July 1, 2015
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on October 06, 2015