Study protocol for the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study

J Comp Eff Res. 2018 Jan;7(1):57-66. doi: 10.2217/cer-2017-0053. Epub 2017 Dec 21.

Abstract

Since 2010, four oral anticoagulants have been approved for marketing in addition to warfarin for treatment of thromboembolic disease. Limited head-to-head data exist comparing these treatments, leaving patients and clinicians with little guidance for selecting a strategy that balances recurrence reduction with bleeding risk. In the dabigatran, apixaban, rivaroxban, edoxaban and warfarin comparative effectiveness research study, we compare all five currently available oral anticoagulant agents for the extended treatment of deep venous thrombosis and pulmonary embolism, as well as no extended treatment, and evaluate whether results differ in specific sub-populations. As our population includes Medicare novel anticoagulant users and large numbers of commercially insured and Medicaid patients, our results will likely be transportable to the majority of US patients experiencing a DVT or pulmonary embolism.

Clinical trials registration: NCT03271450.

Keywords: anticoagulant; comparative effectiveness research; comparative safety; pharmacoepidemiology.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anticoagulants / therapeutic use
  • Antithrombins / therapeutic use
  • Comparative Effectiveness Research / methods*
  • Dabigatran / therapeutic use*
  • Factor Xa Inhibitors / therapeutic use
  • Humans
  • Pulmonary Embolism / drug therapy
  • Pyrazoles / therapeutic use*
  • Pyridines / therapeutic use*
  • Pyridones / therapeutic use*
  • Research Design*
  • Rivaroxaban / therapeutic use*
  • Thiazoles / therapeutic use*
  • Venous Thrombosis / drug therapy
  • Warfarin / therapeutic use*

Substances

  • Anticoagulants
  • Antithrombins
  • Factor Xa Inhibitors
  • Pyrazoles
  • Pyridines
  • Pyridones
  • Thiazoles
  • apixaban
  • Warfarin
  • Rivaroxaban
  • Dabigatran
  • edoxaban

Associated data

  • ClinicalTrials.gov/NCT03271450