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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 February 2015 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02022020
First received: November 25, 2013
Last updated: February 4, 2015
Last verified: February 2015
  Purpose

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
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 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 during 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 anatomic 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: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Detailed Description:

Purpose:

  Eligibility

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

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
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 ClinicalTrials.gov identifier: NCT02022020

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Connecticut
1160.162.38 Boehringer Ingelheim Investigational Site Not yet recruiting
New Britain, Connecticut, United States
United States, Florida
1160.162.15 Boehringer Ingelheim Investigational Site Recruiting
Orlando, Florida, United States
1160.162.18 Boehringer Ingelheim Investigational Site Recruiting
Tampa, Florida, United States
United States, Louisiana
1160.162.22 Boehringer Ingelheim Investigational Site Completed
New Orleans, Louisiana, United States
United States, Massachusetts
1160.162.50 Boehringer Ingelheim Investigational Site Recruiting
Springfield, Massachusetts, United States
United States, New York
1160.162.16 Boehringer Ingelheim Investigational Site Recruiting
Staten Island, New York, United States
United States, Pennsylvania
1160.162.37 Boehringer Ingelheim Investigational Site Recruiting
Philadelphia, Pennsylvania, United States
1160.162.19 Boehringer Ingelheim Investigational Site Recruiting
Philedelphia, Pennsylvania, United States
United States, Tennessee
1160.162.24 Boehringer Ingelheim Investigational Site Recruiting
Nashville, Tennessee, United States
United States, Virginia
1160.162.17 Boehringer Ingelheim Investigational Site Recruiting
Charlottesville, Virginia, United States
Canada, Alberta
1160.162.06 Boehringer Ingelheim Investigational Site Not yet recruiting
Calgary, Alberta, Canada
Canada, British Columbia
1160.162.04 Boehringer Ingelheim Investigational Site Not yet recruiting
Vancouver, British Columbia, Canada
Canada, New Brunswick
1160.162.03 Boehringer Ingelheim Investigational Site Recruiting
Saint John, New Brunswick, Canada
Canada, Nova Scotia
1160.162.02 Boehringer Ingelheim Investigational Site Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
1160.162.10 Boehringer Ingelheim Investigational Site Active, not recruiting
Hamilton, Ontario, Canada
Canada, Quebec
1160.162.05 Boehringer Ingelheim Investigational Site Not yet recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02022020     History of Changes
Other Study ID Numbers: 1160.162
Study First Received: November 25, 2013
Last Updated: February 4, 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

ClinicalTrials.gov processed this record on March 02, 2015