Emulation of the RECORD3 Trial Using Healthcare Claims Data

NCT07599384 | Completed FDA Drug

• 1 other identifier: 2018P002966-RECORD3
• Study Type: observational
• Target: 149,248
• 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

Deep Vein Thrombosis; Pulmonary Embolus

Outcome Measures

Primary Outcomes (1)

• Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 17 days

  The primary outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of any component of the composite endpoint: deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 17 days after elective total knee arthroplasty, comparing rivaroxaban versus enoxaparin.

  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.

Other Outcomes (1)

• Time to first occurrence of fracture or fall

  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.

Study Arms (2)

Enoxaparin

Reference group

Drug: Enoxaparin

Rivaroxaban

Exposure group

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Initiation of rivaroxaban described in electronic health records is used as the exposure.

Also known as: Xarelto

Rivaroxaban

Enoxaparin DRUG

Initiation of enoxaparin described in electronic health records is used as the reference.

Enoxaparin

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

Patients aged 18 years or older undergoing elective total knee arthroplasty.

You may qualify if:

• At least 18 years of age
• Scheduled to undergo elective total knee replacement

You may not qualify if:

• Pregnancy or breastfeeding
• Had active bleeding or high risk of bleeding
• Had contraindications for prophylaxis with enoxaparin
• Drug or alcohol abuse
• Concomitant use of protease inhibitors for the treatment of HIV
• Had planned intermittent pneumatic compression
• Had a requirement for anticoagulant therapy that could not be stopped
• Substantial liver disease
• Severe renal impairment (creatinine clearance \<30 ml per minute)
• Concurrent use of both drugs

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

Venous Thrombosis; Pulmonary Embolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

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: Associate Professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: October 13, 2024
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-05

Locations

US (1)