Status:
UNKNOWN
The DARE Warfarin CER Study
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Harvard Medical School (HMS and HSDM)
Patient-Centered Outcomes Research Institute
Conditions:
Deep Venous Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- 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.
- No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2021
Estimated Enrollment :
416000 Patients enrolled
Trial Details
Trial ID
NCT03271450
Start Date
July 1 2017
End Date
October 30 2021
Last Update
June 23 2021
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120