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Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System (NCT03026556)

Health ResearchTx, LLC (HRTX)
inVentiv Health Clinical (iVH)
United States Department of Defense (DOD)
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
  • Drug: Dabigatran vs. Rivaroxaban
    observed for 6 years
    • Drug: Dabigatran vs. Apixaban
      Observed for 6 years
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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 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, VTE (includes 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

      1 locations

      United States (1)
      • Inventiv Health
        recruiting
        Princeton, New Jersey, United States, 08450
      Status:
      recruiting
      Type:
      Observational
      Phase:
      -
      Start:
      26 January, 2017
      Updated:
      12 June, 2017
      Participants:
      47000
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