Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Deep Vein Thrombosis, Pulmonary Embolus Clinical Trial

Official title:

Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083455
• Other study ID #: 2018P002966-DUP-RECORD1
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: July 22, 2021

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89215
• Est. completion date: July 22, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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]

Related Conditions & MeSH terms

• Deep Vein Thrombosis, Pulmonary Embolus
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban
Any rivaroxaban dispensing claim is used as the exposure group
• Enoxaparin
Any enoxaparin dispensing claim is used as the reference group

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relative hazard of major bleeding	Claims-based algorithm: relative hazard of major bleeding	Through study completion or censoring, up to 36 days