NCT03271450

The DARE Warfarin CER Study

The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 416,000 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Deep Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Dabigatran: extended treatment (e.g at least 90 days)	90 days
DRUG	Dabigatran: extended treatment (e.g at least 180 days)	180 days
DRUG	Dabigatran: extended treatment (e.g at least 270 days)	270 days
DRUG	Apixaban: extended treatment (e.g at least 90 days)	90 days
DRUG	Apixaban: extended treatment (e.g at least 180 days)	180 days
DRUG	Apixaban: extended treatment (e.g at least 270 days)	270 days
DRUG	Rivaroxaban: extended treatment (e.g at least 90 days)	90 days
DRUG	Rivaroxaban: extended treatment (e.g at least 180 days)	180 days
DRUG	Rivaroxaban: extended treatment (e.g at least 270 days)	270 days
DRUG	Edoxaban: extended treatment (e.g at least 90 days)	90 days
DRUG	Edoxaban: extended treatment (e.g at least 180 days)	180 days
DRUG	Edoxaban: extended treatment (e.g at least 270 days)	270 days
DRUG	Warfarin: extended treatment (e.g at least 90 days)	90 days
DRUG	Warfarin: extended treatment (e.g at least 180 days)	180 days
DRUG	Warfarin: extended treatment (e.g at least 270 days)	270 days

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-10-30
• Completion: 2021-10-30
• First posted: 2017-09-05
• Last updated: 2021-06-23

Locations

1 site across 1 country: United States