Comparative Effectiveness of Oral Anticoagulants

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim.

Completed

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

Trial summary

This cohort study plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 5,982 participants
Where: No sites listed yet
Study dates: Apr 2013to Apr 2013
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: Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy

Who may be able to join

A recorded diagnosis of atrial fibrillation (AF).
Initiation of anticoagulant medication (dabigatran or warfarin).
At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score >=1

Who cannot join

Patients with missing or ambiguous age or sex information
Patients with documented evidence of valvular disease
Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
Patients with prior use of any oral anticoagulant

About this study

Official title: Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

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 NCT01847547
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.

Incidence Rate of Stroke
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
Measured: From treatment initiation until end of follow-up; up to 20 months

Secondary outcomes (17)

Incidence Rate of Myocardial Infarction
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Venous Thromboembolism
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Deep Vein Thrombosis
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Pulmonary Embolism
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Lower Gastrointestinal Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Urogenital Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Other Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Transient Ischemic Attack
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Upper Gastrointestinal Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Stroke or Systemic Embolism
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Systemic Embolism
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Ischemic Stroke
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Hemorrhagic Stroke
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Stroke Uncertain Classification
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Intracranial Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Extracranial Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
Measured: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Gastrointestinal Bleeding
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
Measured: From treatment initiation until end of follow-up; up to 20 months

Timeline

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

Apr 2013Apr 2013

First posted7 May 2013 (estimated)
Study startApr 2013
Primary completionApr 2013
Study completionApr 2013

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: 5,982 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01847547
Sponsor's protocol ID: 1160.157
Status last verified: Apr 2014
First submitted: 18 Apr 2013
Last updated: 6 Jun 2014
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?

Official record

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 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Oral Anticoagulants: A Cohort Study
ClinicalTrials.gov ID: NCT01847547
Acronym / sponsor ID: 1160.157
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 5,982 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 7 May 2013 (estimated)
Results: Posted 19 May 2014

Clinical summary

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

Study design

Observational model: Cohort
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: Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy

Key inclusion criteria (3 listed)

A recorded diagnosis of atrial fibrillation (AF).
Initiation of anticoagulant medication (dabigatran or warfarin).
At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score >=1

Key exclusion criteria (4 listed)

Patients with missing or ambiguous age or sex information
Patients with documented evidence of valvular disease
Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
Patients with prior use of any oral anticoagulant

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

Incidence Rate of Stroke
Time frame: From treatment initiation until end of follow-up; up to 20 months
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
Incidence Rate of Major Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

17 secondary outcomes

Incidence Rate of Myocardial Infarction
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Venous Thromboembolism
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Deep Vein Thrombosis
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Pulmonary Embolism
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Lower Gastrointestinal Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Urogenital Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Other Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Transient Ischemic Attack
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Upper Gastrointestinal Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Stroke or Systemic Embolism
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Systemic Embolism
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Ischemic Stroke
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Hemorrhagic Stroke
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Stroke Uncertain Classification
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Intracranial Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Extracranial Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Gastrointestinal Bleeding
Time frame: From treatment initiation until end of follow-up; up to 20 months

Results and safety

Results posted to the registry on 19 May 2014, 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	2,991	2,991
Warfarin	2,991	2,991

Primary outcome: Incidence Rate of Stroke

Time frame: From treatment initiation until end of follow-up; up to 20 months. Number. Unit: events per 1000 person years

Measure	Dabigatran n = 2991	Warfarin n = 2991
Value	29.09	31.59

Dabigatran vs Warfarin: Hazard Ratio (HR): 1.05 (95% CI 0.64 to 1.70), Regression, Cox

Population analysed: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Primary outcome: Incidence Rate of Major Bleeding

Time frame: From treatment initiation until end of follow-up; up to 20 months. Number. Unit: events per 1000 person years

Measure	Dabigatran n = 2991	Warfarin n = 2991
Value	60.00	66.72

Dabigatran vs Warfarin: Hazard Ratio (HR): 0.97 (95% CI 0.69 to 1.36), Regression, Cox

Population analysed: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 20 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran	0 of 2,991 (0%)	0 of 2,991 (0%)	Not reported
Warfarin	0 of 2,991 (0%)	0 of 2,991 (0%)	Not reported

Limitations and caveats (from the sponsor): These first data are limited by small sample size, short follow up, few events resulting in wide confidence intervals. No comparative conclusions are possible. After the feasibility analysis future analysis will increase patient numbers and follow up

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim.

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 4 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 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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 19 May 2014). 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?

Incidence Rate of Stroke (time frame: From treatment initiation until end of follow-up; up to 20 months). 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 NCT01847547.

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 6 Jun 2014.