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The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study (DARE Warfarin CER Study)
Investigator (PI): Gagne, Joshua
Performing Organization (PO): (Current): Brigham and Women's Hospital, Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics / (617) 278-0930
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/NOACs-1511-33068
Funding: Total Award Amount: $2,881,687
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Each year, around half a million Americans experience venous thromboembolic disease, including deep venous thrombosis (DVT) and pulmonary embolism (PE), and between 10 percent and 30 percent of those with DVT or PE die within one month of diagnosis. Fortunately, oral anticoagulants, which are the standard treatment for venous thromboembolic disease, are effective in reducing DVT and PE recurrence. Although these oral anticoagulants are very effective in reducing recurrence of DVT and PE, they also increase bleeding risk. Moreover, the optimal duration of anticoagulation following DVT or PE is unknown. In an attempt to balance the benefits of recurrence reduction with the risk of bleeding, guidelines recommend anticoagulation for at least three months for patients with DVT. However, the guidelines do not provide insight on which oral anticoagulants should be used for the extended treatment of DVT and PE. The proposed study will be the first to compare all five currently available oral anticoagulant agents for the extended treatment of DVT and PE. By comparing all five options, this study will most directly address the pressing clinical question that all patients and their health care providers face when extended anticoagulation treatment is justified: Which of the five oral anticoagulants will best optimize trade-offs in benefits and risks? The proposed Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study (DARE Warfarin CER Study) has four specific aims: (aim 1) compare the safety and effectiveness of extended treatment of venous thromboembolic disease with different new oral anticoagulants (i.e., dabigatran, apixaban, rivaroxaban, edoxaban) and warfarin; (aim 2) conduct validation of key study variables and subgroup analyses; (aim 3) examine heterogeneity in treatment effects across multiple patient factors; and (aim 4) calibrate study results to those of available randomized trials. The study will compare extended treatment (i.e., beyond three months) with all five oral anticoagulants (warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban). The study population will comprise individuals with an initial episode of DVT or PE, and no prior oral anticoagulant use, who complete three months of anticoagulants treatment and continue on to extended treatment. Patients will be identified in the real world using large electronic health care databases. Combined, these databases include information for more than 215 million Americans. Electronic health record data that are linked to the Medicare claims data will be used for the validation subcohort analyses. The proposed primary outcome is major bleeding, a safety outcome. Individual safety outcomes will include intracranial bleeding, gastrointestinal bleeding, and other major bleeding. Effectiveness outcomes include DVT and PE recurrence. We will also investigate all-cause mortality, which combines aspects of both effectiveness and safety.
MeSH Terms:
  • Administration, Oral
  • Anticoagulants /*therapeutic use
  • Comparative Effectiveness Research
  • Dabigatran /*therapeutic use
  • Databases, Factual
  • Hemorrhage /prevention & control
  • Humans
  • Medicare
  • Outcome Assessment, Health Care
  • Pulmonary Embolism /*drug therapy
  • Recurrence
  • Risk
  • Rivaroxaban /*therapeutic use
  • United States
  • Venous Thrombosis /*drug therapy
  • Warfarin /*therapeutic use
Country: United States
State: Massachusetts
Zip Code: 02120
UI: 20164144
CTgovId: NCT03271450
Project Status: Ongoing
Record History: ('2018: Project extended to 2022 ',) ('2017: Project extended to 2021',)