- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04736420
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
July 25, 2023 updated by: Shirley Vichy Wang, Brigham and Women's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
78605
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
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to warfarin users.
The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or warfarin (index date).
We will restrict the analyses to patients with a diagnosis of proximal DVT without symptomatic PE.
Description
Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Inclusion Criteria:
- Confirmed acute symptomatic proximal DVT without symptomatic PE
Exclusion Criteria:
- Age ≤ 18
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE two weeks prior to and including day of enrollment
- Other indications for VKA than DVT and/or PE six months prior to and including day of enrollment
Any of the following six months prior to and including day of enrollment:
- Creatine clearance < 30 ml/min
- Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT>3 ULN
- Bacterial endocarditis
- Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA
- Systolic blood pressure > 180 mgHg or diastolic blood pressure > 110 mgHg
- Childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding
- Life expectancy < 3 months in the last year prior to and including day of enrollment
- Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers two weeks prior to and including day of enrollment
- Symptomatic pulmonary embolism two weeks prior to and including day of enrollment
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Warfarin
Reference group
|
Warfarin dispensing claim is used as the reference group
|
Rivaroxaban
Exposure group
|
Rivaroxaban dispensing claim is used as the exposure group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of venous thromboembolism
Time Frame: Through study completion or point of censoring, up to 12 months
|
Claims-based algorithm: see attached protocol for full definition
|
Through study completion or point of censoring, up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of a major bleeding event
Time Frame: Through study completion or point of censoring, up to 12 months
|
Claims-based algorithm: see attached protocol for full definition
|
Through study completion or point of censoring, up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
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)
September 22, 2020
Primary Completion (Actual)
February 18, 2021
Study Completion (Actual)
February 18, 2021
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 29, 2021
First Posted (Actual)
February 3, 2021
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P002966-DUP-EINSTEIN-DVT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Venous Thromboembolism
-
BayerWithdrawnTotal Hip Replacement | Total Knee Replacement | Prophylaxis, Thromboembolism, Venous
-
University Hospital, BrestRecruitingVenous Thromboembolism (VTE)France
-
University of ArizonaRecruitingPediatric Venous ThromboembolismUnited States
-
National Taiwan University HospitalUnknownDeep Venous ThromboembolismTaiwan
-
BayerCompletedTreatment of Venous ThromboembolismJapan
-
Azidus BrasilUnknownPrevention of Venous ThromboembolismBrazil
-
Ya-Wei XuFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern...RecruitingVenous Thromboembolism (VTE)China
-
Bristol-Myers SquibbCompletedVenous Thromboembolism (VTE)United States
-
Fadoi Foundation, ItalyCompletedPrevention of Venous ThromboembolismItaly
-
Fadoi Foundation, ItalyUniversity Of PerugiaCompletedPrevention of Venous ThromboembolismItaly
Clinical Trials on Warfarin
-
University Hospital, BrestCompletedRecurrent Venous Thromboembolism | Idiopathic Deep Vein ThrombosisFrance
-
University Hospital, BrestCompleted
-
University of PadovaCompleted
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAtrial FibrillationBrazil
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); Duke Clinical Research InstituteTerminatedIdiopathic Pulmonary FibrosisUnited States
-
Azienda Ospedaliera Universitaria PoliclinicoCompletedDeep Vein ThrombosisItaly
-
National University Hospital, SingaporeUnknownIndications for Warfarin TherapySingapore, Malaysia
-
University of KarachiAdvanced Education & Research Center; Karachi Institute of Heart DiseasesRecruitingLeft Atrial Appendage Aneurysm | Mitral StenosisPakistan
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Cerebrovascular Disorders | Atrial Fibrillation | Arrhythmia | Cerebrovascular Accident | Thrombophlebitis | Cerebral Embolism and Thrombosis