The DARE Warfarin CER Study

• Conditions: Deep Venous Thrombosis; Pulmonary Embolism

• Registration Number: NCT03271450
• Lead Sponsor: Brigham and Women's Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-23
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 416000

Inclusion Criteria

Not provided

Exclusion Criteria

1. Any safety outcome between index diagnosis date and index rx date + 90, defined as: intracranial bleed, gastrointestinal bleed, or other major bleed.
2. Any DVT/PE between index diagnosis date and index rx date + 90.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Safety Outcome: Intracranial bleed, Gastrointestinal bleed, Other Major bleed	1-2 Years	Defined as a new episode of either Intracranial bleed, Gastrointestinal bleed or another Major bleed event during follow-up.
Death	1-2 Years	Measured after index prescription date + 90 days and on date on which the event occurred and defined as hospitalization with discharge status code of: 20, 22-29, 40-42
Composite Effectiveness Outcome: Deep Venous Thrombosis, Pulmonary Embolism	1-2 Years	Defined as a new episode of either Deep Venous Thrombosis or Pulmonary Embolism during follow-up.
Composite safety and effectiveness outcome	1-2 years	defined as earlier of safety or DVT/PE outcomes
Composite safety and effectiveness outcome, including death	1-2 years	Measured after index prescription date + 90 days and on date on which the event occurred and defined as hospitalization with discharge status code of: 20, 22-29, 40-42

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States