Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05083455

Collaborator

(none)

89,215

Enrollment

Location

Actual Duration (Months)

8962

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis, Pulmonary Embolus	Drug: Rivaroxaban Drug: Enoxaparin

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.

Study Design

Study Type:

Observational

Actual Enrollment :

89215 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Actual Study Start Date :

Sep 22, 2020

Actual Primary Completion Date :

Jul 21, 2021

Actual Study Completion Date :

Jul 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Enoxaparin Reference group	Drug: Enoxaparin Any enoxaparin dispensing claim is used as the reference group
Rivaroxaban Exposure group	Drug: Rivaroxaban Any rivaroxaban dispensing claim is used as the exposure group Other Names: Xarelto

Arm

Intervention/Treatment

Enoxaparin

Reference group

Drug: Enoxaparin

Any enoxaparin dispensing claim is used as the reference group

Rivaroxaban

Exposure group

Drug: Rivaroxaban

Any rivaroxaban dispensing claim is used as the exposure group

Other Names:

Xarelto

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Relative hazard of major bleeding [Through study completion or censoring, up to 36 days]
Claims-based algorithm: relative hazard of major bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

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]