Deep Vein Thrombosis, Pulmonary EmbolusNCT05083455
Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
An observational study of Deep Vein Thrombosis, Pulmonary Embolus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolus
- What is being tested?
- Rivaroxaban and Enoxaparin
- How many people
- 89,215 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 15 Jun 2026
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to enoxaparin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or enoxaparin (index date). We will restrict the analyses to patients who underwent a total hip arthroplasty.
Who may be able to join
- At least 18 years of age
- Scheduled to undergo elective total hip arthroplasty
Who cannot join
- Scheduled to undergo staged, bilateral hip arthroplasty [Day -30, Day 0]
- Pregnany or breastfeeding [Day -180, Day 0]
- Had active bleeding or high risk of bleeding [Day -180, Day 0]
- Had conditions preventing bilateral venography [Day -30, Day 0]
- Congestive heart failure [Day -180, Day 0]
- Pulmonary hypertension [Day -180, Day 0]
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- Edema of legs [Day -180, Day 0]
- Substantial liver disease [Day -180, Day 0]
- Severe renal impairment (creatinine clearance <30 ml per minute) [Day -180, Day 0]
- Concomitant use of protease inhibitors for the treatment of HIV [Day -180, Day 0]
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolus
- Being tested
- Rivaroxaban, Enoxaparin
- 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.
RivaroxabanDrug
Also called Xarelto
Any rivaroxaban dispensing claim is used as the exposure group
EnoxaparinDrug
Any enoxaparin dispensing claim is used as the reference group
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Reference group Receives: Drug: Enoxaparin | |
| Rivaroxaban | Exposure group Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 days
The primary outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of any component of the composite endpoint: deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 36 days after elective total hip arthroplasty, comparing rivaroxaban versus enoxaparin.
Measured: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days
Secondary outcomes (2)
Time to first occurrence of major bleeding
The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of major bleeding as a control outcome, comparing rivaroxaban versus enoxaparin.
Measured: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days
Time to first occurrence of fracture or fall
The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of fracture or fall as a control outcome, comparing rivaroxaban versus enoxaparin.
Measured: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start22 Sep 2020
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis, Pulmonary EmbolusStudies 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
- Retrospective
- Enrolment
- 89,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083455
- Sponsor's protocol ID
- 2018P002966-DUP-RECORD1
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT05083455
- Acronym / sponsor ID
- 2018P002966-DUP-RECORD1
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89,215 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 19 Oct 2021 (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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | – | Drug: EnoxaparinReference group |
| Rivaroxaban | – | Drug: RivaroxabanExposure group |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to enoxaparin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or enoxaparin (index date). We will restrict the analyses to patients who underwent a total hip arthroplasty.
Key inclusion criteria (2 listed)
- At least 18 years of age
- Scheduled to undergo elective total hip arthroplasty
Key exclusion criteria (10 listed)
- Scheduled to undergo staged, bilateral hip arthroplasty [Day -30, Day 0]
- Pregnany or breastfeeding [Day -180, Day 0]
- Had active bleeding or high risk of bleeding [Day -180, Day 0]
- Had conditions preventing bilateral venography [Day -30, Day 0]
- Congestive heart failure [Day -180, Day 0]
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 |
|---|---|---|
| RivaroxabanAlso: XareltoAny rivaroxaban dispensing claim is used as the exposure group | Drug | Rivaroxaban |
| EnoxaparinAny enoxaparin dispensing claim is used as the reference group | Drug | Enoxaparin |
Primary outcome
Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 days
Time frame: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days
The primary outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of any component of the composite endpoint: deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 36 days after elective total hip arthroplasty, comparing rivaroxaban versus enoxaparin.
2 secondary outcomes
Time to first occurrence of major bleeding
Time frame: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days
Time to first occurrence of fracture or fall
Time frame: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
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 Vein Thrombosis, Pulmonary Embolus, 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 days (time frame: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.