Clinical trial NCT05083455: Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
Official title: Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis, Pulmonary Embolus
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 89215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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 \[Day -180, Day 0\]

Primary outcomes:
measure: Relative hazard of any deep vein thrombosis, non-fatal pulmonary embolism, or death from any cause
timeFrame: Through study completion or censoring, up to 36 days
Secondary outcomes:
measure: Relative hazard of major bleeding
timeFrame: Through study completion or censoring, up to 36 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shirley Wang, PhD, ScM
role: PRINCIPAL_INVESTIGATOR
References: