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

NCT ID: NCT04879407

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98947 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2021-06-11

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 clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

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.

Conditions

Pulmonary Embolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Warfarin

Reference group

Warfarin

Intervention Type: DRUG

Any warfarin dispensing claim is used as the reference group

Rivaroxaban

Exposure group

Rivaroxaban

Intervention Type: DRUG

Any rivaroxaban dispensing claim is used as the exposure group

Interventions

Rivaroxaban

Any rivaroxaban dispensing claim is used as the exposure group

Intervention Type: DRUG

Warfarin

Any warfarin dispensing claim is used as the reference group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed acute symptomatic proximal PE with or without symptomatic DVT

Exclusion Criteria

• 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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shirley Vichy Wang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Wang, PhD, ScM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018P002966-DUP-EINSTEIN-PE

Identifier Type: -

Identifier Source: org_study_id