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Completed

NCT Number: NCT02022020

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

Loading trial locations.

About this study

Purpose:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge

    Time frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.

    Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.

    Emergency Department/Room (ED/ER).

    Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:

    • Ongoing, if symptoms of bleeding not completely resolved at time of discharge;
    • Deceased in case of death;
    • Resolved otherwise.

  2. Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge

    Time frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.

    Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.

  3. Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation

    Time frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.

    Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 27, 2013
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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