Emulation of the RECORD3 Trial Using Healthcare Claims Data

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07599384
Status
Active Not Recruiting

Conditions

  • Deep Vein Thrombosis
  • Pulmonary Embolus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rivaroxaban — DRUG
    Initiation of rivaroxaban described in electronic health records is used as the exposure.
  • Enoxaparin — DRUG
    Initiation of enoxaparin described in electronic health records is used as the reference.

Study Details

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.

Key Dates

Start date
Oct 13, 2024
Status verified
May 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
149,248 participants (actual)

Arms

  • Arm: Enoxaparin
    Reference group
  • Arm: Rivaroxaban
    Exposure group

Primary Outcome Measure

Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 17 days [ Time Frame: From 1 day after fill until earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 17 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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By research site
Brigham and Women's Hospital· Boston, MA

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