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

NCT04879407 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-EINSTEIN-PE
• Study Type: observational
• Target: 98,947
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Relative hazard of recurrent venous thromboembolic events

  Claims-based algorithm: see attached protocol for full definition

  Through study completion or censoring, up to 12 months

Secondary Outcomes (1)

• Relative hazard of major bleeding

  Through study completion or censoring, up to 12 months

Study Arms (2)

Warfarin

Reference group

Drug: Warfarin

Rivaroxaban

Exposure group

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Any rivaroxaban dispensing claim is used as the exposure group

Rivaroxaban

Warfarin DRUG

Any warfarin dispensing claim is used as the reference group

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 acute symptomatic proximal PE with or without symptomatic DVT.

You may qualify if:

• Confirmed acute symptomatic proximal PE with or without symptomatic DVT

You may not qualify if:

• 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 \[Day -14, Day 0\]

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: October 10, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

US (1)