Boston, Massachusetts 02120

  • Venous Thromboembolism

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

DUPLICATE-EINSTEIN-DVT


NCT ID:

NCT04736420


Secondary ID:


Study Acronym:


Brief Title:

Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data


Official Title:

Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

78605


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jessica Franklin, PhD
Principal Investigator
Brigham and Women's Hospital

Study Dates

Start Date:September 22, 2020
Completion Date:February 18, 2021
Completion Type:Actual
Primary Completion Date:February 18, 2021
Primary Completion Type:Actual
Verification Date:May 2021
Last Changed Date:May 6, 2021
First Received Date:January 25, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Relative hazard of venous thromboembolism
Time Frame:Through study completion or point of censoring, up to 12 months
Safety Issues:False
Description:Claims-based algorithm: see attached protocol for full definition
Outcome Type:Secondary Outcome
Measure:Relative hazard of a major bleeding event
Time Frame:Through study completion or point of censoring, up to 12 months
Safety Issues:False
Description:Claims-based algorithm: see attached protocol for full definition

Study Interventions

Intervention Type:Drug
Name:Warfarin
Description:Warfarin dispensing claim is used as the reference group
Arm Name:Warfarin
Intervention Type:Drug
Name:Rivaroxaban
Description:Rivaroxaban dispensing claim is used as the exposure group
Arm Name:Rivaroxaban

Study Arms

Study Arm Type:Other
Arm Name:Warfarin
Description:Reference group
Study Arm Type:Other
Arm Name:Rivaroxaban
Description:Exposure group

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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