The DARE Warfarin CER Study

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

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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2021-10-30

Completion

2021-10-30

Countries

• United States

Study Locations