Atrial FibrillationNCT02043808

The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in United States.

Completed

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

Trial summary

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 25,586 participants
Where: 1 siteUnited States
Study dates: Jan 2014to May 2014
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: NVAF

Who may be able to join

Patients must be continuously enrolled in a health plan during the pre-index period;
Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
Aged 18-89 on the index date;

Who cannot join

Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

Trial locations and contacts

1 site in 1 country.

United States1 site

1160.183.01 Boehringer Ingelheim Investigational Site
Lexington, Massachusetts

Other trials in United States

About this study

Official title: The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Read the detailed description

Study Design:

Retrospective

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 NCT02043808
Study group	Role	What they receive
Dabigatran		Not described
Warfarin		Not described

What is being measured

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

Stroke (Hemorrhagic, Ischemic)
Event rate of stroke (hemorrhagic, ischemic).
Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period)
Major Bleeding
Event rate of major bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period)

Secondary outcomes (15)

Ischemic Stroke
Event rate of ischemic stroke.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period)
Hemorrhagic Stroke
Event rate of hemorrhagic stroke.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major Intracranial Bleeding
Event rate of major intracranial bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major Extracranial Bleeding
Event rate of major extracranial bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major GI Bleeding
Event rate of major gastrointestinal (GI) bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major Upper GI Bleeding
Event rate of major upper gastrointestinal (GI) bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major Lower GI Bleeding
Event rate of major lower gastrointestinal (GI) bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major Urogenital Bleeding
Event rate of major urogenital bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Major Other Bleeding
Event rate of major other bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Transient Ischemic Attack
Event rate of transient ischemic attacks.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Myocardial Infarction
Event rate of myocardial infarction.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Venous Thromboembolism
Event rate of venous thromboembolism.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Deep Vein Thrombosis
Event rate of deep vein thrombosis.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Pulmonary Embolism
Event rate of pulmonary embolism.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).
Death
Event rate of death, due to any cause.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Measured: From October 1, 2009 through July 31, 2013 (the study period).

Timeline

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

Jan 2014May 2014

First posted23 Jan 2014 (estimated)
Study startJan 2014
Primary completionMay 2014
Study completionMay 2014

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
Time perspective: Retrospective
Enrolment: 25,586 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02043808
Sponsor's protocol ID: 1160.183
Status last verified: Jul 2015
First submitted: 10 Jan 2014
Last updated: 3 Jul 2015
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 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis
ClinicalTrials.gov ID: NCT02043808
Acronym / sponsor ID: 1160.183
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 25,586 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Posted 3 Jul 2015

Clinical summary

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

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Detailed description

Study Design:

Retrospective

Study design

Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Dabigatran	–	–
Warfarin	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: NVAF

Key inclusion criteria (5 listed)

Patients must be continuously enrolled in a health plan during the pre-index period;
Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
Aged 18-89 on the index date;

Key exclusion criteria (2 listed)

Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

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

Stroke (Hemorrhagic, Ischemic)
Time frame: From October 1, 2009 through July 31, 2013 (the study period)
Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Major Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period)
Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.

15 secondary outcomes

Ischemic Stroke
Time frame: From October 1, 2009 through July 31, 2013 (the study period)
Hemorrhagic Stroke
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major Intracranial Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major Extracranial Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major GI Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major Upper GI Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major Lower GI Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major Urogenital Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Major Other Bleeding
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Transient Ischemic Attack
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Myocardial Infarction
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Venous Thromboembolism
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Deep Vein Thrombosis
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Pulmonary Embolism
Time frame: From October 1, 2009 through July 31, 2013 (the study period).
Death
Time frame: From October 1, 2009 through July 31, 2013 (the study period).

Results and safety

Results posted to the registry on 3 Jul 2015, 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	12,793	12,793
Warfarin	12,793	12,793

Primary outcome: Stroke (Hemorrhagic, Ischemic)

Time frame: From October 1, 2009 through July 31, 2013 (the study period). Number (95% Confidence Interval). Unit: Events per 1000 person-years

Measure	Dabigatran n = 12793	Warfarin n = 12793
Value	9.15 (7.41 to 11.19)	13.19 (10.74 to 16.05)

Dabigatran vs Warfarin: Crude event rate ratio: 0.69 (95% CI 0.52 to 0.92)

Population analysed: All patients in the post-propensity score matching cohort

Primary outcome: Major Bleeding

Time frame: From October 1, 2009 through July 31, 2013 (the study period). Number (95% Confidence Interval). Unit: Events per 1000 person-years

Measure	Dabigatran n = 12793	Warfarin n = 12793
Value	30.84 (27.55 to 34.42)	37.04 (32.82 to 41.65)

Dabigatran vs Warfarin: Crude event rate ratio: 0.83 (95% CI 0.71 to 0.98)

Population analysed: All patients in the post-propensity score matching cohort

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran	0 of 0	0 of 0	Not reported
Warfarin	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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

1 site in 1 country: 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 1 site in United States.

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 5 inclusion and 2 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 3 Jul 2015). 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?

Stroke (Hemorrhagic, Ischemic) (time frame: From October 1, 2009 through July 31, 2013 (the study period)). The study lists 2 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 NCT02043808.

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 3 Jul 2015.