Status:
COMPLETED
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Brief 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 cl...
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 re...
Eligibility Criteria
Inclusion
- Criteria:
- Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- \- Confirmed acute symptomatic proximal DVT without symptomatic PE
Exclusion
- 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
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
78605 Patients enrolled
Trial Details
Trial ID
NCT04736420
Start Date
September 22 2020
End Date
February 18 2021
Last Update
July 28 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120