Atrial FibrillationNCT03026556
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Dabigatran vs. Rivaroxaban and Dabigatran vs. Apixaban
- Type of treatment
- Pill or oral medicine
- How many people
- 42,534 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2016to 23 Aug 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: NVAF patients, ≥18 years of age, enrolled within the DoD Military Health System, who have newly initiated dabigatran, rivaroxaban, or apixaban. Patients must be treatment naïve from OAC use prior to first (index) NOAC.
Who may be able to join
- Age 18+ on index date
- Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date;
- Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period.
- Patients must have at least 12 months of continuous eligibility prior to the index date;
- Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.
Who cannot join
- Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period
- Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) \& PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):
- Cardiac surgery
- Pericarditis
- Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with "valvular" Afib (pre-period):
- Mitral stenosis
Show all 36Show fewer
- Mitral stenosis with insufficiency
- Mitral valve stenosis and aortic valve stenosis
- Mitral valve stenosis and aortic valve insufficiency
- Diseases of other endocardial structures
- Other and unspecified rheumatic heart diseases
- Open heart valvuloplasty without replacement
- Open and other replacement of unspecified heart valve
- Open and other replacement of aortic valve
- Open and other replacement of mitral valve
- Open and other replacement of pulmonary valve
- Open and other replacement of tricuspid valve
- Heart valve replaced by transplant
- Heart valve replaced by a mechanical device/prosthesis
- Atrioventricular valve repair
- Aortic valve valvuloplasty
- Unlisted procedure, cardiac surgery
- Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic approach
- Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; without cardiopulmonary bypass
- Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; with cardiopulmonary bypass
- Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve
- Valvuloplasty, mitral valve, with cardiopulmonary bypass
- Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring
- Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with or without ring
- Replacement, mitral valve, with cardiopulmonary bypass
- Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach
- Replacement, pulmonary valve
- Valvectomy, tricuspid valve, with cardiopulmonary bypass
- Valvuloplasty, tricuspid valve; without ring insertion
- Valvuloplasty, tricuspid valve; with ring insertion
- Replacement, tricuspid valve, with cardiopulmonary bypass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
- Conditions
- Atrial Fibrillation
- Being tested
- Dabigatran vs. Rivaroxaban, Dabigatran vs. Apixaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran vs. RivaroxabanDrug
observed for 6 years
Dabigatran vs. ApixabanDrug
Observed for 6 years
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran vs. Rivaroxaban | OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC). Receives: Drug: Dabigatran vs. Rivaroxaban | |
| Dabigatran vs. Apixaban | OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC). Receives: Drug: Dabigatran vs. Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:
- The day of discontinuation of the index NOAC exposure;
- The day before a switch to an anticoagulant different from the index exposure;
- The day before a change in dose for the index NOAC;
- The end of continuous eligibility of a patient in the health plan (disenrollment);
- The end of the study observation period; or
- The date of death of the patient.
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Overall Major Bleeding
The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Secondary outcomes (11)
Ischemic Stroke
The event rate of ischemic stroke in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hemorrhagic Stroke
The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Intracranial Bleeding
The event rate of major intracranial bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Extracranial Bleeding
The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major GI Bleeding
The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Urogenital Bleeding
The event rate of major urogenital bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Other Bleeding
The event rate of major other bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Upper GI Bleeding
The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Lower GI Bleeding
The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
TIA
The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
All-cause Mortality
The event rate of all-cause mortality in patients matched on propensity scores without index year.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Measured: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start29 Dec 2016
- Primary completion23 Aug 2017
- Study completion23 Aug 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
- 42,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health ResearchTx, LLC (HRTX), inVentiv Health Clinical, United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026556
- Sponsor's protocol ID
- 1160-0274
- Status last verified
- Feb 2019
- First submitted
- 18 Jan 2017
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System
- ClinicalTrials.gov ID
- NCT03026556
- Acronym / sponsor ID
- 1160-0274
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,534 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Health ResearchTx, LLC (HRTX), inVentiv Health Clinical, United States Department of Defense
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran vs. Rivaroxaban | – | Drug: Dabigatran vs. RivaroxabanOAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC). |
| Dabigatran vs. Apixaban | – | Drug: Dabigatran vs. ApixabanOAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NVAF patients, ≥18 years of age, enrolled within the DoD Military Health System, who have newly initiated dabigatran, rivaroxaban, or apixaban. Patients must be treatment naïve from OAC use prior to first (index) NOAC.
Key inclusion criteria (5 listed)
- Age 18+ on index date
- Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date;
- Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period.
- Patients must have at least 12 months of continuous eligibility prior to the index date;
- Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.
Key exclusion criteria (36 listed)
- Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period
- Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) \& PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):
- Cardiac surgery
- Pericarditis
- Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with "valvular" Afib (pre-period):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran vs. Rivaroxabanobserved for 6 years | Drug | Dabigatran vs. Rivaroxaban |
| Dabigatran vs. ApixabanObserved for 6 years | Drug | Dabigatran vs. Apixaban |
Primary outcome
Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest: 1. The day of discontinuation of the index NOAC exposure; 2. The day before a switch to an anticoagulant different from the index exposure; 3. The day before a change in dose for the index NOAC; 4. The end of continuous eligibility of a patient in the health plan (disenrollment); 5. The end of the study observation period; or 6. The date of death of the patient.
Overall Major Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
11 secondary outcomes
Ischemic Stroke
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hemorrhagic Stroke
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Intracranial Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Extracranial Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major GI Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Urogenital Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Major Other Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Upper GI Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Lower GI Bleeding
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
TIA
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
All-cause Mortality
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 36 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 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 3 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?
Stroke Overall (Hemorrhagic, Ischemic, Uncertain) (time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years). 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?
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 Jun 2019.