Venous ThromboembolismNCT04735523
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
An observational study of Venous Thromboembolism, 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
- Venous Thromboembolism
- What is being tested?
- Dabigatran and Warfarin
- How many people
- 5,350 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 18 Feb 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 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 dabigatran to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of dabigatran to warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT or PE.
Who may be able to join
- Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate.
- Men and women ages 18 years or greater
Who cannot join
- PE satisfying at least one of the following criteria:
- Haemodynamic instability
- OR Embolectomy is indicated or performed
- OR thrombolytic therapy is indicated or performed
- OR suspected source of PE is other than blood clots from the legs
- Actual or anticipated use of vena cava filter
Show all 22Show fewer
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
- Known anaemia
- Need of anticoagulant treatment for disorders other than VTE
- Recent unstable cardiovascular disease
- Elevated AST or ALT > 3x ULN
- Liver disease expected to have any potential impact on survival (severe liver conditions)
- Severe renal impairment
- Contraindications to anticoagulant therapy (not specified)
- Recent or active major bleeding
- Recent brain, eye, or spinal cord injury or surgery
- Malignant or severe, uncontrolled hypertension
- Active infective endocarditis
- Mechanical prosthetic heart valve (recently implanted - RE-ALIGN trial)
- Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
- Patients who have developed transaminase elevations upon exposure to ximelagatran
- Patients considered unsuitable for inclusion by the investigator
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
- Venous Thromboembolism
- Being tested
- Dabigatran, Warfarin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
Dabigatran dispensing claim is used as the exposure group
WarfarinDrug
Warfarin dispensing claim is used as the reference group
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Reference group Receives: Drug: Warfarin | |
| Dabigatran | Exposure group Receives: Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE and cause-specific mortality
Measured: Through study completion (a median of 84-89 days)
Secondary outcomes (2)
Hospital admission for VTE
Measured: Through study completion (a median of 84-89 days)
Cause-specific mortality
Measured: Through study completion (a median of 84-89 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start22 Sep 2020
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- 5,350 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
- NCT04735523
- Sponsor's protocol ID
- 2018P002966-DUP-RE-COVER II
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2021
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT04735523
- Acronym / sponsor ID
- 2018P002966-DUP-RE-COVER II
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,350 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 3 Feb 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 |
|---|---|---|
| Warfarin | – | Drug: WarfarinReference group |
| Dabigatran | – | Drug: DabigatranExposure 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 dabigatran to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of dabigatran to warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT or PE.
Key inclusion criteria (2 listed)
- Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate.
- Men and women ages 18 years or greater
Key exclusion criteria (22 listed)
- PE satisfying at least one of the following criteria:
- Actual or anticipated use of vena cava filter
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
- Known anaemia
- Need of anticoagulant treatment for disorders other than VTE
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 |
|---|---|---|
| DabigatranDabigatran dispensing claim is used as the exposure group | Drug | Dabigatran |
| WarfarinWarfarin dispensing claim is used as the reference group | Drug | Warfarin |
Primary outcome
VTE and cause-specific mortality
Time frame: Through study completion (a median of 84-89 days)
2 secondary outcomes
Hospital admission for VTE
Time frame: Through study completion (a median of 84-89 days)
Cause-specific mortality
Time frame: Through study completion (a median of 84-89 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 1 Aug 2023.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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 Venous Thromboembolism, 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 22 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 1 Aug 2023. 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?
VTE and cause-specific mortality (time frame: Through study completion (a median of 84-89 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 1 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.