Deep Venous ThrombosisNCT03271450
The DARE Warfarin CER Study
An observational study of Deep Venous Thrombosis and Pulmonary Embolism, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thrombosis, Pulmonary Embolism
- What is being tested?
- Dabigatran: extended treatment (e.g at least 90 days), Dabigatran: extended treatment (e.g at least 180 days) and Dabigatran: extended treatment (e.g at least 270 days)
- How many people
- 416,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
- No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: 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.
- Conditions
- Deep Venous Thrombosis, Pulmonary Embolism
- Being tested
- Dabigatran: extended treatment (e.g at least 90 days), Dabigatran: extended treatment (e.g at least 180 days), Dabigatran: extended treatment (e.g at least 270 days), Apixaban: extended treatment (e.g at least 90 days), Apixaban: extended treatment (e.g at least 180 days)
- Keywords
- dabigatran, warfarin, apixaban, edoxaban, extended treatment, oral anticoagulant, rivaroxaban, comparative safety, comparative effectiveness
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran: extended treatment (e.g at least 90 days)Drug
90 days
Dabigatran: extended treatment (e.g at least 180 days)Drug
180 days
Dabigatran: extended treatment (e.g at least 270 days)Drug
270 days
Apixaban: extended treatment (e.g at least 90 days)Drug
90 days
Apixaban: extended treatment (e.g at least 180 days)Drug
180 days
Apixaban: extended treatment (e.g at least 270 days)Drug
270 days
Rivaroxaban: extended treatment (e.g at least 90 days)Drug
90 days
Rivaroxaban: extended treatment (e.g at least 180 days)Drug
180 days
Rivaroxaban: extended treatment (e.g at least 270 days)Drug
270 days
Edoxaban: extended treatment (e.g at least 90 days)Drug
90 days
Edoxaban: extended treatment (e.g at least 180 days)Drug
180 days
Edoxaban: extended treatment (e.g at least 270 days)Drug
270 days
Warfarin: extended treatment (e.g at least 90 days)Drug
90 days
Warfarin: extended treatment (e.g at least 180 days)Drug
180 days
Warfarin: extended treatment (e.g at least 270 days)Drug
270 days
| Study group | Role | What they receive |
|---|---|---|
| Continuer at 90 Days: Dabigatran | Not described Receives: Drug: Dabigatran: extended treatment (e.g at least 90 days) | |
| Continuer at 180 Days: Dabigatran | Not described Receives: Drug: Dabigatran: extended treatment (e.g at least 180 days) | |
| Continuer at 270 Days: Dabigatran | Not described Receives: Drug: Dabigatran: extended treatment (e.g at least 270 days) | |
| Continuer at 90 Days: Apixaban | Not described Receives: Drug: Apixaban: extended treatment (e.g at least 90 days) | |
| Continuer at 180 Days: Apixaban | Not described Receives: Drug: Apixaban: extended treatment (e.g at least 180 days) | |
| Continuer at 270 Days: Apixaban | Not described Receives: Drug: Apixaban: extended treatment (e.g at least 270 days) | |
| Continuer at 90 Days: Rivaroxaban | Not described Receives: Drug: Rivaroxaban: extended treatment (e.g at least 90 days) | |
| Continuer at 180 Days: Rivaroxaban | Not described Receives: Drug: Rivaroxaban: extended treatment (e.g at least 180 days) | |
| Continuer at 270 Days: Rivaroxaban | Not described Receives: Drug: Rivaroxaban: extended treatment (e.g at least 270 days) | |
| Continuer at 90 Days: Edoxaban | Not described Receives: Drug: Edoxaban: extended treatment (e.g at least 90 days) | |
| Continuer at 180 Days: Edoxaban | Not described Receives: Drug: Edoxaban: extended treatment (e.g at least 180 days) | |
| Continuer at 270 Days: Edoxaban | Not described Receives: Drug: Edoxaban: extended treatment (e.g at least 270 days) | |
| Continuer at 90 Days: Warfarin | Not described Receives: Drug: Warfarin: extended treatment (e.g at least 90 days) | |
| Continuer at 180 Days: Warfarin | Not described Receives: Drug: Warfarin: extended treatment (e.g at least 180 days) | |
| Continuer at 270 Days: Warfarin | Not described Receives: Drug: Warfarin: extended treatment (e.g at least 270 days) | |
| Discontinuer at 90 Days: Dabigatran | Not described Receives: Drug: Dabigatran: extended treatment (e.g at least 90 days) | |
| Discontinuer at 180 Days: Dabigatran | Not described Receives: Drug: Dabigatran: extended treatment (e.g at least 180 days) | |
| Discontinuer at 270 Days: Dabigatran | Not described Receives: Drug: Dabigatran: extended treatment (e.g at least 270 days) | |
| Discontinuer at 90 Days: Apixaban | Not described Receives: Drug: Apixaban: extended treatment (e.g at least 90 days) | |
| Discontinuer at 180 Days: Apixaban | Not described Receives: Drug: Apixaban: extended treatment (e.g at least 180 days) | |
| Discontinuer at 270 Days: Apixaban | Not described Receives: Drug: Apixaban: extended treatment (e.g at least 270 days) | |
| Discontinuer at 90 Days: Rivaroxaban | Not described Receives: Drug: Rivaroxaban: extended treatment (e.g at least 90 days) | |
| Discontinuer at 180 Days: Rivaroxaban | Not described Receives: Drug: Rivaroxaban: extended treatment (e.g at least 180 days) | |
| Discontinuer at 270 Days: Rivaroxaban | Not described Receives: Drug: Rivaroxaban: extended treatment (e.g at least 270 days) | |
| Discontinuer at 90 Days: Edoxaban | Not described Receives: Drug: Edoxaban: extended treatment (e.g at least 90 days) | |
| Discontinuer at 180 Days: Edoxaban | Not described Receives: Drug: Edoxaban: extended treatment (e.g at least 180 days) | |
| Discontinuer at 270 Days: Edoxaban | Not described Receives: Drug: Edoxaban: extended treatment (e.g at least 270 days) | |
| Discontinuer at 90 Days: Warfarin | Not described Receives: Drug: Warfarin: extended treatment (e.g at least 90 days) | |
| Discontinuer at 180 Days: Warfarin | Not described Receives: Drug: Warfarin: extended treatment (e.g at least 180 days) | |
| Discontinuer at 270 Days: Warfarin | Not described Receives: Drug: Warfarin: extended treatment (e.g at least 270 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety Outcome: Intracranial bleed, Gastrointestinal bleed, Other Major bleed
Defined as a new episode of either Intracranial bleed, Gastrointestinal bleed or another Major bleed event during follow-up.
Measured: 1-2 Years
Composite Effectiveness Outcome: Deep Venous Thrombosis, Pulmonary Embolism
Defined as a new episode of either Deep Venous Thrombosis or Pulmonary Embolism during follow-up.
Measured: 1-2 Years
Death
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
Measured: 1-2 Years
Composite safety and effectiveness outcome
defined as earlier of safety or DVT/PE outcomes
Measured: 1-2 years
Composite safety and effectiveness outcome, including death
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
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Jul 2017
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 416,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Katsiaryna Bykov, PharmD, ScD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271450
- Sponsor's protocol ID
- 2017P000215
- Status last verified
- Jun 2021
- First submitted
- 24 Aug 2017
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krumme AA, Pawar A, Schneeweiss S, Glynn RJ, Choudhry NK, Kulldorff M, Ortiz AS, Avorn J, Gagne JJ. Study protocol for the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study. J Comp Eff Res. 2018 Jan;7(1):57-66. doi: 10.2217/cer-2017-0053. Epub 2017 Dec 21.
PubMed 29264930
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study
- ClinicalTrials.gov ID
- NCT03271450
- Acronym / sponsor ID
- 2017P000215
- Conditions
- Deep Venous Thrombosis, Pulmonary Embolism
- Keywords
- dabigatran, warfarin, apixaban, edoxaban, extended treatment, oral anticoagulant, rivaroxaban, comparative safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 416,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Patient-Centered Outcomes Research Institute
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 30
| Arm | Type | Receives |
|---|---|---|
| Continuer at 90 Days: Dabigatran | – | Drug: Dabigatran: extended treatment (e.g at least 90 days) |
| Continuer at 180 Days: Dabigatran | – | Drug: Dabigatran: extended treatment (e.g at least 180 days) |
| Continuer at 270 Days: Dabigatran | – | Drug: Dabigatran: extended treatment (e.g at least 270 days) |
| Continuer at 90 Days: Apixaban | – | Drug: Apixaban: extended treatment (e.g at least 90 days) |
| Continuer at 180 Days: Apixaban | – | Drug: Apixaban: extended treatment (e.g at least 180 days) |
| Continuer at 270 Days: Apixaban | – | Drug: Apixaban: extended treatment (e.g at least 270 days) |
| Continuer at 90 Days: Rivaroxaban | – | Drug: Rivaroxaban: extended treatment (e.g at least 90 days) |
| Continuer at 180 Days: Rivaroxaban | – | Drug: Rivaroxaban: extended treatment (e.g at least 180 days) |
| Continuer at 270 Days: Rivaroxaban | – | Drug: Rivaroxaban: extended treatment (e.g at least 270 days) |
| Continuer at 90 Days: Edoxaban | – | Drug: Edoxaban: extended treatment (e.g at least 90 days) |
| Continuer at 180 Days: Edoxaban | – | Drug: Edoxaban: extended treatment (e.g at least 180 days) |
| Continuer at 270 Days: Edoxaban | – | Drug: Edoxaban: extended treatment (e.g at least 270 days) |
| Continuer at 90 Days: Warfarin | – | Drug: Warfarin: extended treatment (e.g at least 90 days) |
| Continuer at 180 Days: Warfarin | – | Drug: Warfarin: extended treatment (e.g at least 180 days) |
| Continuer at 270 Days: Warfarin | – | Drug: Warfarin: extended treatment (e.g at least 270 days) |
| Discontinuer at 90 Days: Dabigatran | – | Drug: Dabigatran: extended treatment (e.g at least 90 days) |
| Discontinuer at 180 Days: Dabigatran | – | Drug: Dabigatran: extended treatment (e.g at least 180 days) |
| Discontinuer at 270 Days: Dabigatran | – | Drug: Dabigatran: extended treatment (e.g at least 270 days) |
| Discontinuer at 90 Days: Apixaban | – | Drug: Apixaban: extended treatment (e.g at least 90 days) |
| Discontinuer at 180 Days: Apixaban | – | Drug: Apixaban: extended treatment (e.g at least 180 days) |
| Discontinuer at 270 Days: Apixaban | – | Drug: Apixaban: extended treatment (e.g at least 270 days) |
| Discontinuer at 90 Days: Rivaroxaban | – | Drug: Rivaroxaban: extended treatment (e.g at least 90 days) |
| Discontinuer at 180 Days: Rivaroxaban | – | Drug: Rivaroxaban: extended treatment (e.g at least 180 days) |
| Discontinuer at 270 Days: Rivaroxaban | – | Drug: Rivaroxaban: extended treatment (e.g at least 270 days) |
| Discontinuer at 90 Days: Edoxaban | – | Drug: Edoxaban: extended treatment (e.g at least 90 days) |
| Discontinuer at 180 Days: Edoxaban | – | Drug: Edoxaban: extended treatment (e.g at least 180 days) |
| Discontinuer at 270 Days: Edoxaban | – | Drug: Edoxaban: extended treatment (e.g at least 270 days) |
| Discontinuer at 90 Days: Warfarin | – | Drug: Warfarin: extended treatment (e.g at least 90 days) |
| Discontinuer at 180 Days: Warfarin | – | Drug: Warfarin: extended treatment (e.g at least 180 days) |
| Discontinuer at 270 Days: Warfarin | – | Drug: Warfarin: extended treatment (e.g at least 270 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
- 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.
- No anticoagulant prescription fill in the 365 days prior to index diagnosis date.
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran: extended treatment (e.g at least 90 days)90 days | Drug | Continuer at 90 Days: Dabigatran, Discontinuer at 90 Days: Dabigatran |
| Dabigatran: extended treatment (e.g at least 180 days)180 days | Drug | Continuer at 180 Days: Dabigatran, Discontinuer at 180 Days: Dabigatran |
| Dabigatran: extended treatment (e.g at least 270 days)270 days | Drug | Continuer at 270 Days: Dabigatran, Discontinuer at 270 Days: Dabigatran |
| Apixaban: extended treatment (e.g at least 90 days)90 days | Drug | Continuer at 90 Days: Apixaban, Discontinuer at 90 Days: Apixaban |
| Apixaban: extended treatment (e.g at least 180 days)180 days | Drug | Continuer at 180 Days: Apixaban, Discontinuer at 180 Days: Apixaban |
| Apixaban: extended treatment (e.g at least 270 days)270 days | Drug | Continuer at 270 Days: Apixaban, Discontinuer at 270 Days: Apixaban |
| Rivaroxaban: extended treatment (e.g at least 90 days)90 days | Drug | Continuer at 90 Days: Rivaroxaban, Discontinuer at 90 Days: Rivaroxaban |
| Rivaroxaban: extended treatment (e.g at least 180 days)180 days | Drug | Continuer at 180 Days: Rivaroxaban, Discontinuer at 180 Days: Rivaroxaban |
| Rivaroxaban: extended treatment (e.g at least 270 days)270 days | Drug | Continuer at 270 Days: Rivaroxaban, Discontinuer at 270 Days: Rivaroxaban |
| Edoxaban: extended treatment (e.g at least 90 days)90 days | Drug | Continuer at 90 Days: Edoxaban, Discontinuer at 90 Days: Edoxaban |
| Edoxaban: extended treatment (e.g at least 180 days)180 days | Drug | Continuer at 180 Days: Edoxaban, Discontinuer at 180 Days: Edoxaban |
| Edoxaban: extended treatment (e.g at least 270 days)270 days | Drug | Continuer at 270 Days: Edoxaban, Discontinuer at 270 Days: Edoxaban |
| Warfarin: extended treatment (e.g at least 90 days)90 days | Drug | Continuer at 90 Days: Warfarin, Discontinuer at 90 Days: Warfarin |
| Warfarin: extended treatment (e.g at least 180 days)180 days | Drug | Continuer at 180 Days: Warfarin, Discontinuer at 180 Days: Warfarin |
| Warfarin: extended treatment (e.g at least 270 days)270 days | Drug | Continuer at 270 Days: Warfarin, Discontinuer at 270 Days: Warfarin |
Primary outcome
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.
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.
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
Composite safety and effectiveness outcome
Time frame: 1-2 years
defined as earlier of safety or DVT/PE outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 29264930Krumme AA, Pawar A, Schneeweiss S, Glynn RJ, Choudhry NK, Kulldorff M, Ortiz AS, Avorn J, Gagne JJ. Study protocol for the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study. J Comp Eff Res. 2018 Jan;7(1):57-66. doi: 10.2217/cer-2017-0053. Epub 2017 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Thrombosis and Pulmonary Embolism, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Safety Outcome: Intracranial bleed, Gastrointestinal bleed, Other Major bleed (time frame: 1-2 Years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.