Clinical trial NCT03026556: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Health ResearchTx, LLC (HRTX)
name: inVentiv Health Clinical (iVH)
name: United States Department of Defense (DOD)
First posted: 2017-01-20
Enrollment: 42534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Overall Major Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Secondary outcomes:
measure: Ischemic Stroke
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Hemorrhagic Stroke
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Major Intracranial Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Major Extracranial Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Major GI Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Major Urogenital Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Major Other Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Upper GI Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: Lower GI Bleeding
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: TIA
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
measure: All-cause Mortality
timeFrame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Inventiv Health
state: New Jersey
Study officials:
References: