Replication of the RELY Anticoagulant Trial in Healthcare Claims Data

NCT04593043 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-RELY
• Study Type: observational
• Target: 78,140
• 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

Dabigatran

Exposure group

Drug: Dabigatran

Interventions

Warfarin DRUG

Warfarin dispensing claim is used as the reference

Warfarin

Dabigatran DRUG

Dabigatran dispensing claim is used as the exposure

Dabigatran

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 dabigatran to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of dabigatran or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation.

You may qualify if:

• \. AF documented as follows: (1a or 1b or 1c)
• a. There is ECG documented AF on the day of screening or randomization
• b. The patient has had a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG within 6 m before randomization
• c. There is documentation of symptomatic or asymptomatic paroxysmal or persistent AF on 2 separate occasions, at least 1 day apart, one of which is within 6 m before randomization.
• \. In addition to documented AF, patients must have one of the following: (2a or 2b or 2c or 2d or 2e)
• a. History of previous stroke, TIA, or systemic embolism
• b. Ejection fraction \<40% documented by echocardiogram, radionuclide or contrast angiogram in the last 6 m
• c. Symptomatic heart failure, New York Heart Association class 2 or higher in the last 6 m
• d. Age ≥75 y
• e. Age ≥65 y and one of the following:
• Diabetes mellitus on treatment
• Documented coronary artery disease (any of: prior myocardial infarction, positive stress test, positive nuclear perfusion study, prior CABG surgery or PCI, angiogram showing ≥75% stenosis in a major coronary artery
• Hypertension requiring medical treatment
• \. Age \>18 y at entry

You may not qualify if:

• \. History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
• \. Severe, disabling stroke within the previous 6 months or Any stroke within the previous 14 days
• \. Conditions associated with an increased risk of bleeding:
• a. Major surgery in the previous month
• c. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
• d. Gastrointestinal hemorrhage within the past year
• e. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
• f. Hemorrhagic disorder or bleeding diathesis
• i. Uncontrolled hypertension (systolic blood pressure \>180 mm Hg and/ or diastolic blood pressure \>100 mm Hg)
• \. Severe renal impairment (estimated creatinine clearance ≤30 mL/min)
• \. Active infective endocarditis
• \. Active liver disease
• \. Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
• \. Anemia (hemoglobin level \< 100g/L) or thrombocytopenia (platelet count \<100 × 109/L)
• \. Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trial because of concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (eg, drug addiction, alcohol abuse)

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; Dabigatran

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; Pyridines; Benzimidazoles

Study Officials

• Shirley Wang, 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: January 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)