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Completed

NCT Number: 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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inventiv Health

Princeton, New Jersey, 08450, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran vs. Rivaroxaban

Drug

observed for 6 years

Dabigatran vs. Apixaban

Drug

Observed for 6 years

Primary outcomes

  1. 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:

    • 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.

  2. 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.

Secondary outcomes

  1. Ischemic Stroke

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  2. Hemorrhagic Stroke

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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.

  3. Major Intracranial Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  4. Major Extracranial Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  5. Major GI Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  6. Major Urogenital Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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.

  7. Major Other Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  8. Upper GI Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  9. Lower GI Bleeding

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  10. TIA

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

  11. All-cause Mortality

    Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

    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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Health ResearchTx, LLC (HRTX)
  • United States Department of Defense
  • inVentiv Health Clinical (iVH)

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2017
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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