Status:
COMPLETED
Replication of the EINSTEIN-PE Anticoagulant Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Pulmonary Embolism
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 PE with or without symptomatic DVT
Exclusion
- Legal lower age limitations \[Day 0, Day 0\]
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE \[Day -14, Day 0\]
- Other indications for VKA than DVT and/or PE \[Day -180, Day 0\]
- Creatinine clearance \<30 ml/min \[Day -180, Day 0\]
- Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\>3x ULN \[Day -180, Day 0\]
- Bacterial endocarditis \[Day -180, Day 0\]
- Life expectancy \<3 months \[Day -365, Day 0\]
- Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA \[Day -180, Day 0\]
- Systolic blood pressure \>180 mgHg or diastolic blood pressure \>110mgHg \[Day -180, Day 0\]
- Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding \[Day -180, Day 0\]
- Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers rifampin \[Day -14, Day 0\]
Key Trial Info
Start Date :
October 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
98947 Patients enrolled
Trial Details
Trial ID
NCT04879407
Start Date
October 10 2020
End Date
June 11 2021
Last Update
July 28 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120