The DARE Warfarin CER Study
Public ClinicalTrials.gov record NCT03271450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03271450
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 416,000 participants
Conditions and interventions
Conditions
Interventions
- Dabigatran: extended treatment (e.g at least 90 days) Drug
- Dabigatran: extended treatment (e.g at least 180 days) Drug
- Dabigatran: extended treatment (e.g at least 270 days) Drug
- Apixaban: extended treatment (e.g at least 90 days) Drug
- Apixaban: extended treatment (e.g at least 180 days) Drug
- Apixaban: extended treatment (e.g at least 270 days) Drug
- Rivaroxaban: extended treatment (e.g at least 90 days) Drug
- Rivaroxaban: extended treatment (e.g at least 180 days) Drug
- Rivaroxaban: extended treatment (e.g at least 270 days) Drug
- Edoxaban: extended treatment (e.g at least 90 days) Drug
- Edoxaban: extended treatment (e.g at least 180 days) Drug
- Edoxaban: extended treatment (e.g at least 270 days) Drug
- Warfarin: extended treatment (e.g at least 90 days) Drug
- Warfarin: extended treatment (e.g at least 180 days) Drug
- Warfarin: extended treatment (e.g at least 270 days) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2017
- Primary completion
- Oct 29, 2021
- Completion
- Oct 29, 2021
- Last update posted
- Jun 22, 2021
2017 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03271450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03271450 live on ClinicalTrials.gov.