Emulation of the RECORD3 Trial Using Healthcare Claims Data

NCT07599384 | Active Not Recruiting 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)

• Composite of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 17 days.

  To compare the comparative effect of rivaroxaban vs enoxaparin on the risk of deep vein thrombosis, nonfatal pulmonary embolism or death from any cause in patients who underwent elective total knee arthroplasty.

  One day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (7 day grace and risk-window), nursing home admission, augmentation/additional exposure or switch to other NOAC or warfarin

Other Outcomes (1)

• Fractures or falls

  One day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (7 day grace and risk-window), nursing home admission, augmentation/additional exposure or switch to other NOAC or warfarin

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. In addition, patients will be excluded with fractures or falls prior to the follow-up time window (30 days) when studying the negative outcome, respectively.

You may qualify if:

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

You may not qualify if:

• Pregnany or breastfeeding \[Day -365, Day 0\]
• Had active bleeding or high risk of bleeding \[Day -183, Day 0\]
• Had contraindications for prophylaxis with enoxaparin \[Day -183, Day 0\]
• Drug or alcohol abuse \[Day -183, Day 0\]
• Concomitant use of protease inhibitors for the treatment of HIV \[Day -183, Day 0\]
• Had planned intermittent pneumatic compression \[Day -183, Day 0\]
• Had a requirement for anticoagulant therapy that could not be stopped \[Day -183, Day 0\]
• Substantial liver disease \[Day -180, Day 0\]
• Severe renal impairment (creatinine clearance \<30 ml per minute) \[Day -180, Day 0\]
• Concurrent use of both drugs \[Day 0, Day 0\]

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

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 (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1)