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Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

NCT05083455 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89215

Last updated 2023-07-27

No results posted yet for this study

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

  • Deep Vein Thrombosis, Pulmonary Embolus

Interventions

DRUG

Rivaroxaban

Any rivaroxaban dispensing claim is used as the exposure group

DRUG

Enoxaparin

Any enoxaparin dispensing claim is used as the reference group

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shirley Wang, PhD, ScM · Brigham and Women's Hospital

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2021-07-21
Completion
2021-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083455 on ClinicalTrials.gov