Atrial FibrillationNCT02022020

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

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 220 participants
Where: 22 sitesin 2 countries
Study dates: Jan 2014to Oct 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: AF patients with bleeding event using Dabigatran etexilate

Who may be able to join

>=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.

Who cannot join

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.

Trial locations and contacts

22 sites in 2 countries.

Country

City, postcode or hospital

22 sites in 2 countries

United States16 sites

Boehringer Ingelheim Investigational Site
Aurora, Colorado
Boehringer Ingelheim Investigational Site
Charlottesville, Virginia
Boehringer Ingelheim Investigational Site
Chesterfield, Missouri
Boehringer Ingelheim Investigational Site
Hackensack, New Jersey
Boehringer Ingelheim Investigational Site
Nashville, Tennessee
Boehringer Ingelheim Investigational Site
New Britain, Connecticut
Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
Boehringer Ingelheim Investigational Site
New York, New York
Boehringer Ingelheim Investigational Site
Norfolk, Virginia
Boehringer Ingelheim Investigational Site
Orlando, Florida
Boehringer Ingelheim Investigational Site
Philedelphia, Pennsylvania
Boehringer Ingelheim Investigational Site
Roanoke, Virginia
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
Boehringer Ingelheim Investigational Site
St Louis, Missouri
Boehringer Ingelheim Investigational Site
Staten Island, New York
Boehringer Ingelheim Investigational Site
Tampa, Florida

Other trials in United States

Canada6 sites

Boehringer Ingelheim Investigational Site
Calgary, Alberta
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
Boehringer Ingelheim Investigational Site
Hamilton, Ontario
Boehringer Ingelheim Investigational Site
Montreal, Quebec
Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

About this study

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

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.

Read the detailed description

Purpose:

Conditions: Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02022020
Study group	Role	What they receive
Group 1		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Oct 2015

First posted27 Dec 2013 (estimated)
Study startJan 2014
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02022020
Sponsor's protocol ID: 1160.162
Status last verified: Dec 2016
First submitted: 25 Nov 2013
Last updated: 31 Jan 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study Assessing the Management of Gastrointestinal and Urogenital Bleeding Events in Patients With Atrial Fibrillation Treated With Dabigatran Etexilate
ClinicalTrials.gov ID: NCT02022020
Acronym / sponsor ID: 1160.162
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 27 Dec 2013 (estimated)
Results: Posted 31 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Purpose:

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Group 1	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: AF patients with bleeding event using Dabigatran etexilate

Key inclusion criteria (3 listed)

>=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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 31 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran (Pradax® in Canada; Pradaxa® in the United States)	220	220

Primary outcome: 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.. Number. Unit: Percentage of participants

Measure	Dabigatran (Pradax® in Canada; Pradaxa® in the United States) n = 220
Ongoing	19.1
Resolved	76.8
Deceased	4.1

Population analysed: Patients who received treatment at two countries (United States and Canada).

Primary outcome: 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.. Number. Unit: Percentage of participants

Measure	Dabigatran (Pradax® in Canada; Pradaxa® in the United States) n = 220
Any general intervention	77.3
Medications	13.6
Surgery	6.8
Therapeutic procedures	9.5
Transfusion/infusion	36.8
Discontinuation of dabigatran	71.4
No interventions	22.7

Population analysed: Patients who received treatment at two countries (United States and Canada).

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

Measure	Dabigatran (Pradax® in Canada; Pradaxa® in the United States) n = 220
GI Bleed	73.2
Upper GI Bleed	15.5
Lower GI Bleed	45.9
GI Bleed - Location Unknown	12.7
GU Bleed	28.6
Both GI and GU	0.2

Population analysed: Patients who received treatment at two countries (United States and Canada).

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran (Pradax® in Canada; Pradaxa® in the United States	184 of 220 (83.6%)	79 of 220 (35.9%)	Not reported

Limitations and caveats (from the sponsor): Limitations of the data sources included completeness of information available in terms of potential lack of outcome data, medical history data and co-medications. Key limitations: 1. Generalizability. 2. Data quality. 3. Data availability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

22 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.