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

NCT05086081 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-ISAR-REACT5
• Study Type: observational
• Target: 28,389
• 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

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relative hazard of hospital admission for MI, hospital admission for stroke, or death

  Through study completion or censoring, up to 12 months

• Relative hazard of major bleeding

  Through study completion or censoring, up to 12 months

Study Arms (2)

Prasugrel

Reference group

Drug: Prasugrel 10mg

Ticagrelor

Exposure group

Drug: Ticagrelor 90mg

Interventions

Ticagrelor 90mg DRUG

Any ticagrelor dispensing claim is used as the exposure group

Ticagrelor

Prasugrel 10mg DRUG

Any prasugrel dispensing claim is used as the reference group

Prasugrel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will involve a new user, parallel group, retrospective cohort study design comparing ticagrelor 90 mg twice daily to prasugrel 10 mg daily. The patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of ticagrelor or prasugrel (index date). We will restrict the analyses to patients with an acute coronary syndrome, with or without ST-segment elevation, who were scheduled to undergo coronary angiography.

You may qualify if:

• 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

You may not qualify if:

• 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 \[-14, 0\]

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

Acute Coronary Syndrome

Interventions

Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring

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: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 20, 2021
• Study Start: October 10, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)