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

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT02022020

Run by

Boehringer Ingelheim

People needed

220

Starts

2014-01-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=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.

You may not qualify if…

• 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.

Where it is running

• Boehringer Ingelheim Investigational Site — Aurora, Colorado, United States
• Boehringer Ingelheim Investigational Site — New Britain, Connecticut, United States
• Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• Boehringer Ingelheim Investigational Site — New Orleans, Louisiana, United States
• Boehringer Ingelheim Investigational Site — Springfield, Massachusetts, United States
• Boehringer Ingelheim Investigational Site — Chesterfield, Missouri, United States
• Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• Boehringer Ingelheim Investigational Site — Hackensack, New Jersey, United States
• Boehringer Ingelheim Investigational Site — New York, New York, United States
• Boehringer Ingelheim Investigational Site — Staten Island, New York, United States
• Boehringer Ingelheim Investigational Site — Philedelphia, Pennsylvania, United States
• Boehringer Ingelheim Investigational Site — Nashville, Tennessee, United States
• Boehringer Ingelheim Investigational Site — Charlottesville, Virginia, United States
• Boehringer Ingelheim Investigational Site — Norfolk, Virginia, United States
• Boehringer Ingelheim Investigational Site — Roanoke, Virginia, United States
• Boehringer Ingelheim Investigational Site — Calgary, Alberta, Canada
• Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
• Boehringer Ingelheim Investigational Site — Saint John, New Brunswick, Canada
• Boehringer Ingelheim Investigational Site — Halifax, Nova Scotia, Canada
• Boehringer Ingelheim Investigational Site — Hamilton, Ontario, Canada
• Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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