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The DARE Warfarin CER Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271450
Recruitment Status : Enrolling by invitation
First Posted : September 5, 2017
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
Harvard Medical School
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Joshua J Gagne, 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.

Condition or disease Intervention/treatment
Deep Venous Thrombosis Pulmonary Embolism Drug: 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)

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Study Type : Observational
Estimated Enrollment : 416000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Death [ Time Frame: 1-2 Years ]
    Measured after index prescription date + 90 days and on date on which the event occurred



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Inpatient stay with diagnosis code of DVT/PE, 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. Patients can enter the cohort only once (not multiple times).
  • Prescription fill for an anticoagulant ([generic name=dabigatran, apixaban , rivaroxaban, edoxaban, or warfarin ) ] within 7 days of and including index diagnosis date. Set earliest anticoagulant prescription as index generic and index rx date.
  • No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
  • Continuous 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 any other anticoagulants during this period.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271450


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Patient-Centered Outcomes Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joshua J Gagne, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03271450    
Other Study ID Numbers: 2017P000215
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua J Gagne, Brigham and Women's Hospital:
dabigatran
warfarin
apixaban
edoxaban
extended treatment
oral anticoagulant
rivaroxaban
comparative safety
comparative effectiveness
Additional relevant MeSH terms:
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Warfarin
Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Dabigatran
Apixaban
Edoxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action