Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

NCT ID: NCT05083455

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2021-07-22

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.

Detailed Description

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Conditions

Deep Vein Thrombosis, Pulmonary Embolus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Enoxaparin

Reference group

Enoxaparin

Intervention Type: DRUG

Any enoxaparin dispensing claim is used as the reference group

Rivaroxaban

Exposure group

Rivaroxaban

Intervention Type: DRUG

Any rivaroxaban dispensing claim is used as the exposure group

Interventions

Rivaroxaban

Any rivaroxaban dispensing claim is used as the exposure group

Intervention Type: DRUG

Enoxaparin

Any enoxaparin dispensing claim is used as the reference group

Intervention Type: DRUG

Other Intervention Names

Xarelto

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shirley Vichy Wang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Wang, PhD, ScM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2018P002966-DUP-RECORD1

Identifier Type: -

Identifier Source: org_study_id