Status:
COMPLETED
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-120 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
- Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- Eligible cohort entry dates:
- Market availability of dabigatran in the U.S. for treatment of deep vein thrombosis and pulmonary embolism started on April 7, 2014
- For Medicare: April 7, 2014 - December 31, 2017 (end of available data)
- For Marketscan: April 7, 2014 - December 31, 2018 (end of available data)
- For Optum: April 7, 2014 - March 31, 2020 (end of available data)
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
5350 Patients enrolled
Trial Details
Trial ID
NCT04735523
Start Date
September 22 2020
End Date
February 18 2021
Last Update
August 1 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120