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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086081
• Other study ID #: 2018P002966-DUP-ISAR-REACT5
• Status: Completed
• Start date: October 10, 2020
• Est. completion date: September 10, 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: 28389
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Criteria:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

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]

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• Ticagrelor 90mg
Any ticagrelor dispensing claim is used as the exposure group
• Prasugrel 10mg
Any prasugrel 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 composite of death, myocardial infarction, or stroke at 1 year after randomization	Claims-based algorithm: Relative hazard of composite of death, myocardial infarction, or stroke at 1 year after randomization	Through study completion or censoring, up to 12 months
Secondary	Relative hazard of hospital admission for MI, hospital admission for stroke, or death	Claims-based algorithm: Relative hazard of hospital admission for MI, hospital admission for stroke, or death	Through study completion or censoring, up to 12 months
Secondary	Relative hazard of major bleeding	Claims-based algorithm: relative hazard of major bleeding	Through study completion or censoring, up to 12 months