NCT02022020|CompletedResults

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

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

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

1160.162

Study Type

observational

Target

220

Locations

2 countries

Sites

Timeline

RegisteredDec 2013

StartedJan 2014

CompletionOct 2015

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

220

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2014

Geographic Reach

2 countries

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

November 25, 2013

Completed

1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed

5 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

January 31, 2017

Completed

Last Updated

January 31, 2017

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

November 25, 2013

Results QC Date

October 5, 2016

Last Update Submit

December 8, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
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.
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
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.
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
Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.
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.

Study Arms (1)

Group 1

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

AF patients with bleeding event using Dabigatran etexilate

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.

Contact the study team to confirm eligibility.