CompletedNot Applicable

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

United States, Canada220 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

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

Timeframe: 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.

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

Trial details

NCT IDNCT02022020

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-10

Results submitted2016-10-05

View on ClinicalTrials.gov More Atrial Fibrillation trials