Replication of the ROCKET-AF Anticoagulant Trial in Healthcare Claims Data

NCT04593056 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-ROCKET-AF
• Study Type: observational
• Target: 102,636
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Relative hazard of composite outcome of Stroke and Systemic Embolism

  Relative hazard of composite outcome of Stroke and Systemic Embolism - Please refer to uploaded protocol for full definition due to size limitations.

  [Time Frame: Through study completion (a median of 98-119 days)]

Study Arms (2)

Warfarin

Reference group

Drug: Warfarin

Rivaroxaban

Exposure group

Drug: Rivaroxaban

Interventions

Warfarin DRUG

Warfarin dispensing claim is used as the reference

Warfarin

Rivaroxaban DRUG

Rivaroxaban dispensing claim is used as the exposure

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will involve a new user, parallel group, cohort study design comparing rivaroxaban to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of rivaroxaban or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation.

You may qualify if:

• \. Patients 18 years of age or older
• \. Non-valvular atrial fibrillation
• \. History of prior ischemic stroke, TIA, systemic embolism or two or more of the following risk factors:
• a. Heart failure and/or left ventricular ejection fraction ≤35%
• b. Hypertension (defined as use of antihypertensive medications within 6 months before the screening visit or persistent systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg)
• c. Patients 75 years of age or older
• d. Diabetes mellitus (defined as a history of type 1 or type 2 diabetes mellitus or use of antidiabetic medications within 6 months before screening visit)

You may not qualify if:

• \. Cardiac-related conditions
• a. Hemodynamically significant mitral valve stenosis
• b. Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
• e. Known presence of atrial myxoma or left ventricular thrombus
• f. Active endocarditis
• \. Hemorrhage-related risk criteria
• a. Active internal bleeding
• b. History of or condition associated with increased bleeding risk including, but not limited to:
• Major surgical procedure or trauma within 30 days before the randomization visit
• Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
• History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
• Chronic hemorrhagic disorder
• Known intracranial neoplasm, arteriovenous malformation, or aneurysm
• d. Platelet count \< \<90,000/μL at the screening visit
• e. Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham And Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin; Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: September 1, 2020
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

US (1)