Replication of the ISAR-REACT 5 Antiplatelet Trial in Healthcare Claims Data

NCT ID: NCT05086081

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28389 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2021-09-10

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.

Conditions

Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Prasugrel

Reference group

Prasugrel 10mg

Intervention Type: DRUG

Any prasugrel dispensing claim is used as the reference group

Ticagrelor

Exposure group

Ticagrelor 90mg

Intervention Type: DRUG

Any ticagrelor dispensing claim is used as the exposure group

Interventions

Ticagrelor 90mg

Any ticagrelor dispensing claim is used as the exposure group

Intervention Type: DRUG

Prasugrel 10mg

Any prasugrel dispensing claim is used as the reference group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Hospitalization for unstable angina or acute MI AND age >= 18 years Days [ACS admission]
• STEMI OR NSTEMI/unstable angina (during admission) + 1 of the following

• >= 60 years old Days [ACS]
• >= 3 risk factors for coronary artery disease
• Diabetes mellitus
• Chronic renal disease
• Carotid stenosis >= 50% or cerebral revascularization
• Peripheral artery disease Days [-365, ACS]
• Aspirin use
• Angina Days [-7, ACS]
• Prior MI or CABG any time prior

Exclusion Criteria

• Acute complication PCI Days [-30, ACS admission]
• History of any stroke or TIA Days [all available data, 0]
• Intracranial neoplasm, intracranial AVM, intracranial neoplasm Days [-180, 0]
• Active bleeding Days [-180, 0]
• Platelet count < 100.000/uL Days [-180, 0]
• Anemia (hemoglobin < 10 g/dL) Days [-180, 0]
• Chronic renal insufficiency requiring dialysis Days [-180, 0]
• Moderate to severe hepatic dysfunction Days [-180, 0]
• Increased risk of bradycardia events Days [-180, 0]
• Life expectancy, 1 year Days [-180, 0]
• Pregnancy Days [-180, 0]
• Concomitant therapy CYP3A inhibitors, CYP3A substrates, or strong CYP3A inducers Days [-14, 0]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shirley Vichy Wang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2018P002966-DUP-ISAR-REACT5

Identifier Type: -

Identifier Source: org_study_id