Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

NCT05083455 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-RECORD1
• Study Type: observational
• Target: 89,215
• 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)

• Relative hazard of any deep vein thrombosis, non-fatal pulmonary embolism, or death from any cause

  Claims-based algorithm: relative hazard of any deep vein thrombosis, non-fatal pulmonary embolism, or death from any cause.

  Through study completion or censoring, up to 36 days

Secondary Outcomes (1)

• Relative hazard of major bleeding

  Through study completion or censoring, up to 36 days

Study Arms (2)

Enoxaparin

Reference group

Drug: Enoxaparin

Rivaroxaban

Exposure group

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Any rivaroxaban dispensing claim is used as the exposure group

Also known as: Xarelto

Rivaroxaban

Enoxaparin DRUG

Any enoxaparin dispensing claim is used as the reference group

Enoxaparin

Eligibility Criteria

• Age: 18 Years - 120 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 enoxaparin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or enoxaparin (index date). We will restrict the analyses to patients who underwent a total hip arthroplasty.

You may qualify if:

• At least 18 years of age
• Scheduled to undergo elective total hip arthroplasty

You may not qualify if:

• Scheduled to undergo staged, bilateral hip arthroplasty \[Day -30, Day 0\]
• Pregnany or breastfeeding \[Day -180, Day 0\]
• Had active bleeding or high risk of bleeding \[Day -180, Day 0\]
• Had conditions preventing bilateral venography \[Day -30, Day 0\]
• Congestive heart failure \[Day -180, Day 0\]
• Pulmonary hypertension \[Day -180, Day 0\]
• Edema of legs \[Day -180, Day 0\]
• Substantial liver disease \[Day -180, Day 0\]
• Severe renal impairment (creatinine clearance \<30 ml per minute) \[Day -180, Day 0\]
• Concomitant use of protease inhibitors for the treatment of HIV \[Day -180, Day 0\]

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: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 19, 2021
• Study Start: September 22, 2020
• Primary Completion: July 21, 2021
• Study Completion: July 22, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)