The DARE Warfarin CER Study

June 17, 2021 updated by: Katsiaryna Bykov, PharmD, ScD, Brigham and Women's Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort derived from a commercial database, MarketScan, and Medicare Research Identifiable Files using data from 2009-2015. Cohort data will be updated as new data come in through 2019.

Description

Inclusion criteria:

  1. 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.
  2. 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.
  3. No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
  4. 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:

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Continuer at 90 Days: Dabigatran
Drug: Dabigatran: extended treatment (e.g at least 90 days)
90 days
Continuer at 180 Days: Dabigatran
Drug: Dabigatran: extended treatment (e.g at least 180 days)
180 days
Continuer at 270 Days: Dabigatran
Drug: Dabigatran: extended treatment (e.g at least 270 days)
270 days
Continuer at 90 Days: Apixaban
Drug: Apixaban: extended treatment (e.g at least 90 days)
90 days
Continuer at 180 Days: Apixaban
Drug: Apixaban: extended treatment (e.g at least 180 days)
180 days
Continuer at 270 Days: Apixaban
Drug: Apixaban: extended treatment (e.g at least 270 days)
270 days
Continuer at 90 Days: Rivaroxaban
Drug: Rivaroxaban: extended treatment (e.g at least 90 days)
90 days
Continuer at 180 Days: Rivaroxaban
Drug: Rivaroxaban: extended treatment (e.g at least 180 days)
180 days
Continuer at 270 Days: Rivaroxaban
Drug: Rivaroxaban: extended treatment (e.g at least 270 days)
270 days
Continuer at 90 Days: Edoxaban
Drug: Edoxaban: extended treatment (e.g at least 90 days)
90 days
Continuer at 180 Days: Edoxaban
Drug: Edoxaban: extended treatment (e.g at least 180 days)
180 days
Continuer at 270 Days: Edoxaban
Drug: Edoxaban: extended treatment (e.g at least 270 days)
270 days
Continuer at 90 Days: Warfarin
Drug: Warfarin: extended treatment (e.g at least 90 days)
90 days
Continuer at 180 Days: Warfarin
Drug: Warfarin: extended treatment (e.g at least 180 days)
180 days
Continuer at 270 Days: Warfarin
Drug: Warfarin: extended treatment (e.g at least 270 days)
270 days
Discontinuer at 90 Days: Dabigatran
Drug: Dabigatran: extended treatment (e.g at least 90 days)
90 days
Discontinuer at 180 Days: Dabigatran
Drug: Dabigatran: extended treatment (e.g at least 180 days)
180 days
Discontinuer at 270 Days: Dabigatran
Drug: Dabigatran: extended treatment (e.g at least 270 days)
270 days
Discontinuer at 90 Days: Apixaban
Drug: Apixaban: extended treatment (e.g at least 90 days)
90 days
Discontinuer at 180 Days: Apixaban
Drug: Apixaban: extended treatment (e.g at least 180 days)
180 days
Discontinuer at 270 Days: Apixaban
Drug: Apixaban: extended treatment (e.g at least 270 days)
270 days
Discontinuer at 90 Days: Rivaroxaban
Drug: Rivaroxaban: extended treatment (e.g at least 90 days)
90 days
Discontinuer at 180 Days: Rivaroxaban
Drug: Rivaroxaban: extended treatment (e.g at least 180 days)
180 days
Discontinuer at 270 Days: Rivaroxaban
Drug: Rivaroxaban: extended treatment (e.g at least 270 days)
270 days
Discontinuer at 90 Days: Edoxaban
Drug: Edoxaban: extended treatment (e.g at least 90 days)
90 days
Discontinuer at 180 Days: Edoxaban
Drug: Edoxaban: extended treatment (e.g at least 180 days)
180 days
Discontinuer at 270 Days: Edoxaban
Drug: Edoxaban: extended treatment (e.g at least 270 days)
270 days
Discontinuer at 90 Days: Warfarin
Drug: Warfarin: extended treatment (e.g at least 90 days)
90 days
Discontinuer at 180 Days: Warfarin
Drug: Warfarin: extended treatment (e.g at least 180 days)
180 days
Discontinuer at 270 Days: Warfarin
Drug: Warfarin: extended treatment (e.g at least 270 days)
270 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Safety Outcome: Intracranial bleed, Gastrointestinal bleed, Other Major bleed
Time Frame: 1-2 Years
Defined as a new episode of either Intracranial bleed, Gastrointestinal bleed or another Major bleed event during follow-up.
1-2 Years
Composite Effectiveness Outcome: Deep Venous Thrombosis, Pulmonary Embolism
Time Frame: 1-2 Years
Defined as a new episode of either Deep Venous Thrombosis or Pulmonary Embolism during follow-up.
1-2 Years
Death
Time Frame: 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
1-2 Years
Composite safety and effectiveness outcome
Time Frame: 1-2 years
defined as earlier of safety or DVT/PE outcomes
1-2 years
Composite safety and effectiveness outcome, including death
Time Frame: 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
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Medical School (HMS and HSDM)
Patient-Centered Outcomes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017P000215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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