Replication of the ARISTOTLE Anticoagulant Trial in Healthcare Claims Data

NCT04593030 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-ARISTOTLE
• Study Type: observational
• Target: 220,518
• 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 days)]

Study Arms (2)

Warfarin

Reference group

Drug: Warfarin

Apixaban

Exposure group

Drug: Apixaban

Interventions

Warfarin DRUG

Warfarin dispensing claim is used as the reference

Warfarin

Apixaban DRUG

Apixaban dispensing claim is used as the exposure

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 apixaban to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of apixaban or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation.

You may qualify if:

• \. Age ≥ 18 years
• \. Atrial fibrillation - either of the following:
• a. In atrial fibrillation or atrial flutter not due to a reversible cause and documented by ECG at the time of enrollment
• b. If not in atrial fibrillation/flutter at the time of enrollment, must have atrial fibrillation/flutter documented on two separate occasions, not due to a reversible cause at least 2 weeks apart in the 12 months prior to enrollment. Atrial fibrillation/flutter may be documented by ECG, or as an episode lasting at least one minute on a rhythm strip, Holter recording, or intracardiac electrogram (from an implanted pacemaker or defibrillator)
• \. One or more of the following risk factor(s) for stroke:
• a. Age 75 years or older
• b. Prior stroke, TIA, or systemic embolus
• c. Either symptomatic congestive heart failure within 3 months or left ventricular dysfunction with an LV ejection fraction (LVEF) ≤ 40% by echocardiography, radionuclide study or contrast angiography
• d. Diabetes mellitus
• e. Hypertension requiring pharmacological treatment

You may not qualify if:

• \. Clinically significant (moderate or severe) mitral stenosis
• \. Increased bleeding risk that is believed to be a contraindication to oral anticoagulation (e.g. previous intracranial hemorrhage)
• \. Conditions other than atrial fibrillation that require chronic anticoagulation (e.g. prosthetic mechanical heart valve)
• \. Persistent, uncontrolled hypertension (systolic BP \> 180 mm Hg, or diastolic BP \> 100 mm Hg)
• \. Active infective endocarditis
• \. Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel, ticlopidine)
• \. Severe comorbid condition with life expectancy of ≤ 1 year
• \. Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical
• \. Recent ischemic stroke (within 7 days)
• \. Severe renal insufficiency (serum creatinine \> 2.5 mg/dL or a calculated creatinine clearance \< 25 mL/min, See Section 6.3.2.2)
• \. Platelet count ≤ 100,000/ mm3
• \. Hemoglobin \< 9 g/dL
• \. Women of child bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy

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; apixaban

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

Study Officials

• Jessica Franklin, PhD

  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: Associate Professor of Medicine

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 27, 2023

Record last verified: 2023-07

Locations

US (1)