Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Brigham and Women's Hospital89,215 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

89,215

Conditions

Deep Vein Thrombosis, Pulmonary Embolus

Interventions

RivaroxabanDRUG

Any rivaroxaban dispensing claim is used as the exposure group

EnoxaparinDRUG

Any enoxaparin dispensing claim is used as the reference group

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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 \[Day -180, Day 0\]

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 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 36 days after elective total hip arthroplasty, comparing rivaroxaban versus enoxaparin.

Time frame: From 1 day after fill until the 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 36 days

Secondary Outcomes

Time to first occurrence of major bleeding

The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of major bleeding as a control outcome, comparing rivaroxaban versus enoxaparin.

Time to first occurrence of fracture or fall

The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of fracture or fall as a control outcome, comparing rivaroxaban versus enoxaparin.

Data from ClinicalTrials.gov

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