Atrial FibrillationNCT02081807

Sequential Expansion of Comparative Effectiveness of Anticoagulants

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 cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 221,228 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2014to 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 initiating oral anticoagulation therapy

Who may be able to join

A recorded diagnosis of atrial fibrillation.
Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
At least 18 years of age on the date of anticoagulant initiation.
Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) score at least 1

Who cannot join

Patients with missing or ambiguous age or sex information.
Patients with evidence of valvular disease.
Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation

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: Sequential Expansion of 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 NCT02081807
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, or Stroke of Uncertain Classification)
The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.
Measured: From October 2010 to September 2015 (the study period)
Major Bleeding
The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).
Measured: From October 2010 to September 2015 (the study period)

Secondary outcomes (17)

Stroke or Systemic Embolism
The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification).
Measured: From October 2010 to September 2015 (the study period)
Systemic Embolism
The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism.
Measured: From October 2010 to September 2015 (the study period)
Ischemic Stroke
The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction
Measured: From October 2010 to September 2015 (the study period)
Hemorrhagic Stroke
The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH)
Measured: From October 2010 to September 2015 (the study period)
Stroke Uncertain Classification
The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease).
Measured: From October 2010 to September 2015 (the study period)
Major Intracranial Bleeding
The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage
Measured: From October 2010 to September 2015 (the study period)
Major Extra-cranial Bleeding
The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding).
Measured: From October 2010 to September 2015 (the study period)
Major Gastrointestinal (GI) Bleeding
The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding).
Measured: From October 2010 to September 2015 (the study period)
Major Upper Gastrointestinal Bleeding
The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method).
Measured: From October 2010 to September 2015 (the study period)
Major Lower Gastrointestinal Bleeding
The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13, Hemorrhage of rectum and anus: 569.3x, Angiodysplasia of intestine with hemorrhage: 569.85, Blood in stool: 578.1x, Hemorrhage of GI tract, unspecified: 578.9
Measured: From October 2010 to September 2015 (the study period)
Major Urogenital Bleeding
The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7, Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0, 285.1, 285.9). Across databases, only one event for dabigatran versus no event among warfarin initiators observed. Across database, four events for rivaroxaban versus no event among warfarin initiators observed. Across database, no events for apixaban and warfarin observed. Therefore HR estimate is not possible.
Measured: From October 2010 to September 2015 (the study period)
Other Major Bleeding
The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x, Hemopericardium: 423.0x, Hemoptysis: 786.3x, Epistaxis: 784.7x, Hemorrhage not specified 459.0x, Acute posthemorrhagic anemia 285.1x
Measured: From October 2010 to September 2015 (the study period)
Transient Ischemic Attack (TIA)
The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis
Measured: From October 2010 to September 2015 (the study period)
Myocardial Infarction (MI)
The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is < 3 days
Measured: From October 2010 to September 2015 (the study period)
Venous Thromboembolism (VTE)
The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)).
Measured: From October 2010 to September 2015 (the study period)
Deep Vein Thrombosis (DVT)
The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Validated algorithm: ICD-9 451.1x, ICD-9 451.2x,ICD-9 451.81, ICD-9 451.9x, ICD-9 453.1x, ICD-9 453.2x, ICD-9 453.8x, ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis)
Measured: From October 2010 to September 2015 (the study period)
Pulmonary Embolism (PE)
The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction)
Measured: From October 2010 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.

7 Mar 20141 Nov 2017

First posted7 Mar 2014 (estimated)
Study start7 Mar 2014
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: 221,228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02081807
Sponsor's protocol ID: 1160.207
Status last verified: Sep 2019
First submitted: 6 Mar 2014
Last updated: 2 Oct 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

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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study
ClinicalTrials.gov ID: NCT02081807
Acronym / sponsor ID: 1160.207
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 221,228 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 7 Mar 2014 (actual)
Primary completion: 1 Nov 2017 (actual)
Study completion: 1 Nov 2017 (actual)
First posted: 7 Mar 2014 (estimated)
Results: Posted 2 Oct 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	–	–

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 (4 listed)

A recorded diagnosis of atrial fibrillation.
Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
At least 18 years of age on the date of anticoagulant initiation.
Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) score at least 1

Key exclusion criteria (5 listed)

Patients with missing or ambiguous age or sex information.
Patients with evidence of valvular disease.
Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation

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, or Stroke of Uncertain Classification)
Time frame: From October 2010 to September 2015 (the study period)
The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.
Major Bleeding
Time frame: From October 2010 to September 2015 (the study period)
The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).

17 secondary outcomes

Stroke or Systemic Embolism
Time frame: From October 2010 to September 2015 (the study period)
Systemic Embolism
Time frame: From October 2010 to September 2015 (the study period)
Ischemic Stroke
Time frame: From October 2010 to September 2015 (the study period)
Hemorrhagic Stroke
Time frame: From October 2010 to September 2015 (the study period)
Stroke Uncertain Classification
Time frame: From October 2010 to September 2015 (the study period)
Major Intracranial Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Major Extra-cranial Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Major Gastrointestinal (GI) Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Major Upper Gastrointestinal Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Major Lower Gastrointestinal Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Major Urogenital Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Other Major Bleeding
Time frame: From October 2010 to September 2015 (the study period)
Transient Ischemic Attack (TIA)
Time frame: From October 2010 to September 2015 (the study period)
Myocardial Infarction (MI)
Time frame: From October 2010 to September 2015 (the study period)
Venous Thromboembolism (VTE)
Time frame: From October 2010 to September 2015 (the study period)
Deep Vein Thrombosis (DVT)
Time frame: From October 2010 to September 2015 (the study period)
Pulmonary Embolism (PE)
Time frame: From October 2010 to September 2015 (the study period)

Results and safety

Results posted to the registry on 2 Oct 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
Optum Clinformatics - Dabigatran	7,668	7,668
Optum Clinformatics - Warfarin	26,149	26,149
Optum Clinformatics - Rivaroxaban	14,852	14,852
Optum Clinformatics - Apixaban	9,112	9,112
MarketScan - Dabigatran	27,456	27,456
MarketScan - Warfarin	76,055	76,055
MarketScan - Rivaroxaban	40,207	40,207
MarketScan - Apixaban	19,729	19,729

Primary outcome: Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)

Time frame: From October 2010 to September 2015 (the study period). Number (95% Confidence Interval). Unit: Incidence rate per 100 person-years

Measure	Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) n = 6125	Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) n = 6125	MarketScan - Dabigatran vs. Warfarin (Dabigatran) n = 23323	MarketScan - Dabigatran vs. Warfarin (Warfarin) n = 23323	Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban) n = 10373	Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin) n = 10373	MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban) n = 25147	MarketScan - Rivaroxaban vs. Warfarin (Warfarin) n = 25147	Optum Clinformatics - Apixaban vs. Warfarin (Apixaban) n = 7065	Optum Clinformatics - Apixaban vs. Warfarin (Warfarin) n = 7065	MarketScan - Apixaban vs. Warfarin (Apixaban) n = 12523	MarketScan - Apixaban vs. Warfarin (Warfarin) n = 12523
Value	0.90 (0.60 to 1.30)	1.01 (0.66 to 1.50)	0.64 (0.51 to 0.80)	0.99 (0.80 to 1.20)	0.80 (0.56 to 1.11)	1.02 (0.72 to 1.39)	0.78 (0.64 to 0.94)	1.09 (0.90 to 1.31)	1.08 (0.74 to 1.53)	1.26 (0.86 to 1.80)	0.62 (0.44 to 0.84)	1.16 (0.87 to 1.51)

Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) vs Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin): Hazard Ratio (HR): 1.00 (95% CI 0.57 to 1.76), Regression, Cox
MarketScan - Dabigatran vs. Warfarin (Dabigatran) vs MarketScan - Dabigatran vs. Warfarin (Warfarin): Hazard Ratio (HR): 0.69 (95% CI 0.52 to 0.94), Regression, Cox
Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) vs Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) vs MarketScan - Dabigatran vs. Warfarin (Dabigatran) vs MarketScan - Dabigatran vs. Warfarin (Warfarin): Hazard Ratio (HR): 0.75 (95% CI 0.58 to 0.98), Regression, Cox

Population analysed: Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.

Primary outcome: Major Bleeding

Time frame: From October 2010 to September 2015 (the study period). Number (95% Confidence Interval). Unit: Incidence rate per 100 person-years

Measure	Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) n = 6125	Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) n = 6125	MarketScan - Dabigatran vs. Warfarin (Dabigatran) n = 23323	MarketScan - Dabigatran vs. Warfarin (Warfarin) n = 23323	Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban) n = 10373	Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin) n = 10373	MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban) n = 25147	MarketScan - Rivaroxaban vs. Warfarin (Warfarin) n = 25147	Optum Clinformatics - Apixaban vs. Warfarin (Apixaban) n = 7065	Optum Clinformatics - Apixaban vs. Warfarin (Warfarin) n = 7065	MarketScan - Apixaban vs. Warfarin (Apixaban) n = 12523	MarketScan - Apixaban vs. Warfarin (Warfarin) n = 12523
Value	2.43 (1.91 to 3.05)	5.23 (4.35 to 6.24)	4.36 (4.00 to 4.74)	6.06 (5.58 to 6.56)	6.2 (5.5 to 7.0)	6.3 (5.5 to 7.2)	6.9 (6.5 to 7.4)	7.5 (7.0 to 8.0)	3.33 (2.69 to 4.07)	6.83 (5.80 to 7.99)	4.25 (3.74 to 4.80)	7.96 (7.15 to 8.83)

Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) vs Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin): Hazard Ratio (HR): 0.51 (95% CI 0.38 to 0.69), Regression, Cox
MarketScan - Dabigatran vs. Warfarin (Dabigatran) vs MarketScan - Dabigatran vs. Warfarin (Warfarin): Hazard Ratio (HR): 0.76 (95% CI 0.68 to 0.86), Regression, Cox
Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) vs Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) vs MarketScan - Dabigatran vs. Warfarin (Dabigatran) vs MarketScan - Dabigatran vs. Warfarin (Warfarin): Hazard Ratio (HR): 0.72 (95% CI 0.65 to 0.80), Regression, Cox

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Individual safety reporting was not applicable for this study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Optum Clinformatics - Dabigatran	0 of 0	0 of 0
Optum Clinformatics - Warfarin	0 of 0	0 of 0
Optum Clinformatics - Rivaroxaban	0 of 0	0 of 0
Optum Clinformatics - Apixaban	0 of 0	0 of 0
MarketScan - Dabigatran	0 of 0	0 of 0
MarketScan - Warfarin	0 of 0	0 of 0
MarketScan - Rivaroxaban	0 of 0	0 of 0
MarketScan - Apixaban	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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

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 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 2 Oct 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 2 Oct 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 (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) (time frame: From October 2010 to September 2015 (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 NCT02081807.

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 2 Oct 2019.