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

Atrial Fibrillation Clinical Trial

Official title:

An Observational Study Assessing the Management of Gastrointestinal and Urogenital Bleeding Events in Patients With Atrial Fibrillation Treated With Dabigatran Etexilate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022020
• Other study ID #: 1160.162
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: October 27, 2015
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Canada	1160.162.06 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1160.162.02 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	1160.162.10 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1160.162.05 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1160.162.03 Boehringer Ingelheim Investigational Site	Saint John	New Brunswick
Canada	1160.162.04 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
United States	1160.162.44 Boehringer Ingelheim Investigational Site	Aurora	Colorado
United States	1160.162.17 Boehringer Ingelheim Investigational Site	Charlottesville	Virginia
United States	1160.162.49 Boehringer Ingelheim Investigational Site	Chesterfield	Missouri
United States	1160.162.45 Boehringer Ingelheim Investigational Site	Hackensack	New Jersey
United States	1160.162.24 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	1160.162.38 Boehringer Ingelheim Investigational Site	New Britain	Connecticut
United States	1160.162.22 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1160.162.32 Boehringer Ingelheim Investigational Site	New York	New York
United States	1160.162.57 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	1160.162.15 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	1160.162.19 Boehringer Ingelheim Investigational Site	Philedelphia	Pennsylvania
United States	1160.162.46 Boehringer Ingelheim Investigational Site	Roanoke	Virginia
United States	1160.162.58 Boehringer Ingelheim Investigational Site	San Francisco	California
United States	1160.162.50 Boehringer Ingelheim Investigational Site	Springfield	Massachusetts
United States	1160.162.29 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	1160.162.16 Boehringer Ingelheim Investigational Site	Staten Island	New York
United States	1160.162.18 Boehringer Ingelheim Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of patients with index event safety outcomes (ongoing/resolved/deceased)		at time of discharge	No
Primary	Frequencies of patients receiving different type of interventions to stop the index event		until discharge	No
Primary	Frequencies of bleeding types and anatomic locations of the index event		at time of presentation	No