Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
416000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-07-01
Study Completion Date
2021-10-30
Brief Summary
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Approximately half a million Americans annually experience venous thromboembolic disease, including deep venous thrombosis (DVT) and pulmonary embolism (PE). Since 2010, four new oral anticoagulants have been approved for marketing in addition to the vitamin K antagonist warfarin. Very limited head-to-head data exists comparing these treatment options, leaving patients, clinicians, and other stakeholders with little guidance for selecting the best strategy that balances recurrence reduction with risk of bleeding. In the DARE Warfarin CER Study, the researchers compare all five currently available oral anticoagulant agents for the extended treatment of DVT and PE, as well as no extended treatment. This study also aims to evaluate whether treatment heterogeneity exists for specific populations, such as older patients or those with renal dysfunction. In a secondary aim, the study will also leverage a database of linked electronic health record-insurance claims to validate diagnosis definitions and account for potential residual confounding by factors unmeasured in claims data. As the patient population includes all Medicare novel anticoagulant users and large numbers of commercially insured and Medicaid patients, the results will likely be transportable to the majority of US patients experiencing a DVT or PE. Pursuant to the objectives of the Patient-Centered Outcomes Research Institute, a study advisory committee consisting of key stakeholders will be actively involved in the study design and dissemination of results.
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Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
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UNKNOWN
Detailed Description
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Conditions
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Deep Venous Thrombosis
Pulmonary Embolism
Study Design
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Observational Model Type
COHORT
Study Time Perspective
OTHER
Study Groups
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Continuer at 90 Days: Dabigatran
Dabigatran: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Continuer at 180 Days: Dabigatran
Dabigatran: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Continuer at 270 Days: Dabigatran
Dabigatran: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Continuer at 90 Days: Apixaban
Apixaban: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Continuer at 180 Days: Apixaban
Apixaban: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Continuer at 270 Days: Apixaban
Apixaban: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Continuer at 90 Days: Rivaroxaban
Rivaroxaban: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Continuer at 180 Days: Rivaroxaban
Rivaroxaban: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Continuer at 270 Days: Rivaroxaban
Rivaroxaban: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Continuer at 90 Days: Edoxaban
Edoxaban: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Continuer at 180 Days: Edoxaban
Edoxaban: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Continuer at 270 Days: Edoxaban
Edoxaban: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Continuer at 90 Days: Warfarin
Warfarin: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Continuer at 180 Days: Warfarin
Warfarin: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Continuer at 270 Days: Warfarin
Warfarin: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Discontinuer at 90 Days: Dabigatran
Dabigatran: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Discontinuer at 180 Days: Dabigatran
Dabigatran: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Discontinuer at 270 Days: Dabigatran
Dabigatran: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Discontinuer at 90 Days: Apixaban
Apixaban: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Discontinuer at 180 Days: Apixaban
Apixaban: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Discontinuer at 270 Days: Apixaban
Apixaban: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Discontinuer at 90 Days: Rivaroxaban
Rivaroxaban: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Discontinuer at 180 Days: Rivaroxaban
Rivaroxaban: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Discontinuer at 270 Days: Rivaroxaban
Rivaroxaban: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Discontinuer at 90 Days: Edoxaban
Edoxaban: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Discontinuer at 180 Days: Edoxaban
Edoxaban: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Discontinuer at 270 Days: Edoxaban
Edoxaban: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Discontinuer at 90 Days: Warfarin
Warfarin: extended treatment (e.g at least 90 days)
Intervention Type
DRUG
90 days
Discontinuer at 180 Days: Warfarin
Warfarin: extended treatment (e.g at least 180 days)
Intervention Type
DRUG
180 days
Discontinuer at 270 Days: Warfarin
Warfarin: extended treatment (e.g at least 270 days)
Intervention Type
DRUG
270 days
Interventions
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Dabigatran: extended treatment (e.g at least 90 days)
90 days
Intervention Type
DRUG
Dabigatran: extended treatment (e.g at least 180 days)
180 days
Intervention Type
DRUG
Dabigatran: extended treatment (e.g at least 270 days)
270 days
Intervention Type
DRUG
Apixaban: extended treatment (e.g at least 90 days)
90 days
Intervention Type
DRUG
Apixaban: extended treatment (e.g at least 180 days)
180 days
Intervention Type
DRUG
Apixaban: extended treatment (e.g at least 270 days)
270 days
Intervention Type
DRUG
Rivaroxaban: extended treatment (e.g at least 90 days)
90 days
Intervention Type
DRUG
Rivaroxaban: extended treatment (e.g at least 180 days)
180 days
Intervention Type
DRUG
Rivaroxaban: extended treatment (e.g at least 270 days)
270 days
Intervention Type
DRUG
Edoxaban: extended treatment (e.g at least 90 days)
90 days
Intervention Type
DRUG
Edoxaban: extended treatment (e.g at least 180 days)
180 days
Intervention Type
DRUG
Edoxaban: extended treatment (e.g at least 270 days)
270 days
Intervention Type
DRUG
Warfarin: extended treatment (e.g at least 90 days)
90 days
Intervention Type
DRUG
Warfarin: extended treatment (e.g at least 180 days)
180 days
Intervention Type
DRUG
Warfarin: extended treatment (e.g at least 270 days)
270 days
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Inpatient stay with diagnosis code of DVT/PE (see Appendix A), 1/1/2010 - 9/30/2015 for which the patient has at least 365 days continuous medical and pharmacy eligibility prior and no other inpatient stays with DVT/PE diagnosis. Set discharge date as index diagnosis date. Take only the first eligible episode for a patient, if multiple.
2. Prescription fill for an anticoagulant \[generic name=dabigatran (150mg), apixaban (2.5mg, 5mg, 10mg), rivaroxaban (15mg, 20mg), edoxaban (30mg, 60mg), or warfarin\] within 30 days of and including index diagnosis date. Set earliest anticoagulant prescription as index generic and date as index rx date.
3. No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
4. Continuous enrollment and use of an anticoagulant for the first 90 days including and following the index rx date, defined as no gaps in therapy \>7 days. For each patient, assign a variable to indicate whether the patient filled an anticoagulant with a different generic name as index during this period.
2. Prescription fill for an anticoagulant \[generic name=dabigatran (150mg), apixaban (2.5mg, 5mg, 10mg), rivaroxaban (15mg, 20mg), edoxaban (30mg, 60mg), or warfarin\] within 30 days of and including index diagnosis date. Set earliest anticoagulant prescription as index generic and date as index rx date.
3. No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
4. Continuous enrollment and use of an anticoagulant for the first 90 days including and following the index rx date, defined as no gaps in therapy \>7 days. For each patient, assign a variable to indicate whether the patient filled an anticoagulant with a different generic name as index during this period.
Exclusion Criteria
1. Any safety outcome between index diagnosis date and index rx date + 90, defined as: intracranial bleed, gastrointestinal bleed, or other major bleed.
2. Any DVT/PE between index diagnosis date and index rx date + 90.
2. Any DVT/PE between index diagnosis date and index rx date + 90.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Sponsor Role
collaborator
Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
Brigham and Women's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Katsiaryna Bykov, PharmD, ScD
Instructor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Site Status
Countries
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United States
References
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Krumme AA, Pawar A, Schneeweiss S, Glynn RJ, Choudhry NK, Kulldorff M, Ortiz AS, Avorn J, Gagne JJ. 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.
Reference Type
DERIVED
Other Identifiers
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2017P000215
Identifier Type: -
Identifier Source: org_study_id
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