Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction

NCT07610577 | Completed FDA Drug

• 1 other identifier: P2Y12-Inhibitor-Use-and-Costs
• Study Type: observational
• Target: 377,753
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe temporal trends in the use and costs of clopidogrel, ticagrelor, and prasugrel in Germany and the United States.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute myocardial infarction; AMI; Myocardial infarction; MI; Ticagrelor; Prasugrel; Clopidogrel; Evidence

Outcome Measures

Primary Outcomes (2)

• Population-level trends in age- and sex-standardized proportions of clopidogrel, ticagrelor, and prasugrel initiators over time

  To evaluate temporal trends in the age- and sex-standardized use of clopidogrel, ticagrelor, and prasugrel among adults initiating P2Y12 inhibitor therapy after acute myocardial infarction in Germany and the US between 2011 and 2024.

  2011 to 2024

• Population-level trends in consumer price index-adjusted net 12-month costs of clopidogrel, ticagrelor, and prasugrel over time

  To evaluate temporal trends in the consumer price index-adjusted 12-month treatment costs of clopidogrel, ticagrelor, and prasugrel in Germany and the US between 2011 and 2024.

  2011 to 2024

Other Outcomes (5)

• Population-level trends in age- and sex-standardized 1-year cumulative incidence of MACE over time

  1 day after cohort entry date until the first of outcome, disenrollment, 365 days after cohort entry.

• Population-level trends in age- and sex-standardized 1-year cumulative incidence of bleeding-related hospitalizations over time

  1 day after cohort entry date until the first of outcome, disenrollment, 365 days after cohort entry.

• Estimated population-level drug cost savings associated with replacement of ticagrelor with prasugrel in clinical practice in the US

  Q4 2019 to Q4 2024

Study Arms (3)

Initiators of clopidogrel

Exposure group

Drug: Clopidogrel

Initiators of prasugrel

Exposure group

Drug: Prasugrel

Initiators of ticagrelor

Exposure group

Drug: Ticagrelor

Interventions

Clopidogrel DRUG

Initiation of clopidogrel in healthcare claims is used as the exposure.

Initiators of clopidogrel

Prasugrel DRUG

Initiation of prasugrel in healthcare claims is used as the exposure.

Initiators of prasugrel

Ticagrelor DRUG

Initiation of ticagrelor in healthcare claims is used as the exposure.

Initiators of ticagrelor

Eligibility Criteria

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

Study Population

Adults aged ≥18 years with acute myocardial infarction who initiated outpatient treatment with clopidogrel, ticagrelor, or prasugrel.

You may qualify if:

• Adults aged ≥18 years
• Acute myocardial infarction
• Initiation of outpatient treatment with clopidogrel, ticagrelor, or prasugrel

You may not qualify if:

• Prior use of clopidogrel, ticagrelor, or prasugrel
• Initiation of more than one study drug on the cohort entry date
• Missing age or sex information
• Insufficient baseline claims enrollment
• TICAGRELOR-TO-PRASUGREL COST-SAVING ANALYSIS IN THE UNITED STATES
• Eligibility Criteria
• Adults aged ≥18 years
• Acute myocardial infarction
• Initiation of outpatient treatment with ticagrelor
• INDUSTRY PAYMENT ANALYSIS IN THE UNITED STATES
• Eligibility Criteria
• General and research payment records in the CMS Open Payments database
• Ticagrelor or prasugrel listed as the associated drug
• PROVIDER-LEVEL PRESCRIBING ANALYSIS
• Eligibility Criteria

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

Myocardial Infarction

Interventions

Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nils Kruger, MD

  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: Instructor in Medicine

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start: November 1, 2025
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

US (1)