The DARE Warfarin CER Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/28/2018 |
| Start Date: | July 1, 2017 |
| End Date: | October 1, 2021 |
The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study
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.
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.
Inclusion Criteria:
- Inpatient stay with diagnosis code of DVT/PE, 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. Patients can enter
the cohort only once (not multiple times).
- Prescription fill for an anticoagulant ([generic name=dabigatran, apixaban ,
rivaroxaban, edoxaban, or warfarin ) ] within 7 days of and including index diagnosis
date. Set earliest anticoagulant prescription as index generic and index rx date.
- No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
- Continuous 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 any other anticoagulants during this
period.
Exclusion Criteria:
- Any safety outcome between index diagnosis date and index rx date + 90, defined as:
intracranial bleed, gastrointestinal bleed, or other major bleed.
- Any DVT/PE between index diagnosis date and index rx date + 90
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