Anticoagulant Utilization Pattern

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

This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 333,664 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2013to 1 Nov 2017
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 at risk for stroke treated with oral anticoagulation

Who may be able to join

A recorded diagnosis of atrial fibrillation
Initiation of oral anticoagulant medication
Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score >=1
At least 18 years of age on the date of anticoagulant initiation

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 first dispensing
Patients with prior use of any oral anticoagulant

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02120

Other trials in United States

About this study

Official title: A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation

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 NCT01847560
Study group	Role	What they receive
Dabigatran		Not described
Warfarin or other New Oral Anticoagulant (NOAC)		Not described

What is being measured

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

Description of the Characteristics of Anticoagulant Initiators
The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
Measured: From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
Measured: From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Measured: From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Measured: From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Measured: From January 2009 to September 2015 (The study period)

Secondary outcomes (1)

Treatment Persistence Over Time
Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.
Measured: From January 2009 to September 2015 (The study period)

Timeline

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

17 Apr 20131 Nov 2017

First posted7 May 2013 (estimated)
Study start17 Apr 2013
Primary completion1 Nov 2017
Study completion1 Nov 2017

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: 333,664 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01847560
Sponsor's protocol ID: 1160.177
Status last verified: Mar 2019
First submitted: 18 Apr 2013
Last updated: 27 Jun 2019
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

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Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
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Not yet recruiting
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Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
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RecruitingObservational study
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation
ClinicalTrials.gov ID: NCT01847560
Acronym / sponsor ID: 1160.177
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 333,664 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Apr 2013 (actual)
Primary completion: 1 Nov 2017 (actual)
Study completion: 1 Nov 2017 (actual)
First posted: 7 May 2013 (estimated)
Results: Posted 27 Jun 2019

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 or other New Oral Anticoagulant (NOAC)	–	–

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 at risk for stroke treated with oral anticoagulation

Key inclusion criteria (4 listed)

A recorded diagnosis of atrial fibrillation
Initiation of oral anticoagulant medication
Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score >=1
At least 18 years of age on the date of anticoagulant initiation

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 first dispensing
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

Description of the Characteristics of Anticoagulant Initiators
Time frame: From January 2009 to September 2015 (The study period)
The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
Percentage of Patients Initiating Specific Anticoagulant
Time frame: From January 2009 to September 2015 (The study period)
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
Time frame: From January 2009 to September 2015 (The study period)
Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
Time frame: From January 2009 to September 2015 (The study period)
Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
Time frame: From January 2009 to September 2015 (The study period)
Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.

1 secondary outcome

Treatment Persistence Over Time
Time frame: From January 2009 to September 2015 (The study period)

Results and safety

Results posted to the registry on 27 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort UnitedHealth Dabigatran Users	13,464	13,464
Cohort UnitedHealth Rivaroxaban Users	19,955	19,955
Cohort UnitedHealth Apixaban Users	9,731	9,731
Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)	56,655	56,655
Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)	27,731	27,731
Cohort MarketScan Dabigatran Users	28,343	28,343
Cohort MarketScan Rivaroxaban Users	40,971	40,971
Cohort MarketScan Apixaban Users	19,829	19,829
Cohort MarketScan WarfarinUsers (After Dabigatran Available)	77,547	77,547
Cohort MarketScan WarfarinUsers(Before Dabigatran Available)	39,438	39,438

Primary outcome: Description of the Characteristics of Anticoagulant Initiators

Time frame: From January 2009 to September 2015 (The study period). Mean (Standard Deviation). Unit: Scores on a scale

Measure	Cohort UnitedHealth Dabigatran Users n = 13464	Cohort UnitedHealth Warfarin Users n = 56655	Cohort UnitedHealth Rivaroxaban Users n = 19955	Cohort UnitedHealth Apixaban Users n = 9731	Cohort MarketScan Dabigatran Users n = 28343	Cohort MarketScan Warfarin Users n = 77547	Cohort MarketScan Rivaroxaban Users n = 40971	Cohort MarketScan Apixaban Users n = 19829
CHA2DS2-VASc score	3.41 (1.73)	4.30 (1.75)	3.59 (1.75)	3.82 (1.72)	2.92 (1.58)	3.62 (1.69)	3.12 (1.68)	3.34 (1.73)
HAS-BLED score	2.52 (1.15)	2.91 (1.18)	2.63 (1.15)	2.76 (1.16)	2.18 (1.02)	2.51 (1.12)	2.32 (1.1)	2.47 (1.14)

Population analysed: All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time.

Primary outcome: Percentage of Patients Initiating Specific Anticoagulant

Time frame: From January 2009 to September 2015 (The study period). Number. Unit: Percentage of initiators (%)

Measure	Warfarin Users n = 609201	Dabigatran Users n = 609201	Rivaroxaban Users n = 609201	Apixaban Users n = 609201
January 2009 - September2010	15.7	NA	NA	NA
October2010 - June2011	5.4	2.1	NA	NA
July2011 -Dec 2011	2.9	2.2	NA	NA
January2012-June2012	3.4	1.9	1.5	NA
July2012-December2012	2.9	1.3	1.5	NA
January2013-June2013	2.3	0.8	1.8	0.3
July2013-December2013	2.0	0.6	1.9	0.7
January2014-June2014	1.7	0.5	2.2	1.0

Population analysed: Source cohort in a calendar time window includes all patients with at least one day eligibility. A random date within the time window selected and set as the index date. Patients dispensed of an anticoagulant before assigned index date will be removed, unless they are identified as new initiators for that particular time period.

Primary outcome: Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran

Time frame: From January 2009 to September 2015 (The study period). Number. Unit: Percentage of initiators (%)

Measure	Cohort UnitedHealth Dabigatran Users n = 13464	Cohort MarketScan Dabigatran Users n = 28343
150 milligram (mg)	90.7	90.7
75 mg	9.3	9.3

Population analysed: Patients initiating treatment in source cohort.

Primary outcome: Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban

Time frame: From January 2009 to September 2015 (The study period). Number. Unit: Percentage of initiators (%)

Measure	Cohort UnitedHealth Apixaban Users n = 9731	Cohort MarketScan Apixaban Users n = 19829
5 mg	82.4	84.4
2.5 mg	17.6	15.6

Population analysed: Patients initiating treatment in source cohort.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety related information was not captured during this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Cohort UnitedHealth Dabigatran Users	0 of 0	0 of 0
Cohort UnitedHealth Rivaroxaban Users	0 of 0	0 of 0
Cohort UnitedHealth Apixaban Users	0 of 0	0 of 0
Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)	0 of 0	0 of 0
Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)	0 of 0	0 of 0
Cohort MarketScan Dabigatran Users	0 of 0	0 of 0
Cohort MarketScan Rivaroxaban Users	0 of 0	0 of 0
Cohort MarketScan Apixaban Users	0 of 0	0 of 0
Cohort MarketScan WarfarinUsers (After Dabigatran Available)	0 of 0	0 of 0
Cohort MarketScan WarfarinUsers(Before Dabigatran Available)	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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 4 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 27 Jun 2019. 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 27 Jun 2019). 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?

Description of the Characteristics of Anticoagulant Initiators (time frame: From January 2009 to September 2015 (The study period)). The study lists 5 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 NCT01847560.

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 27 Jun 2019.