Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction

June 1, 2026 updated by: Nils Krüger, MD, Brigham and Women's Hospital
This study aims to describe temporal trends in the use and costs of clopidogrel, ticagrelor, and prasugrel in Germany and the United States.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral P2Y12 inhibitors are a cornerstone of secondary prevention after acute myocardial infarction. In randomized trials, the potent P2Y12 inhibitors ticagrelor and prasugrel reduced ischemic events compared with clopidogrel. More recently, head-to-head comparisons between ticagrelor and prasugrel confirmed prasugrel's noninferiority and/or superiority compared with ticagrelor. The extent to which this evolving evidence has been incorporated into practice across healthcare systems remains unclear. Therefore, this study aims to describe temporal trends in P2Y12 inhibitor use and associated treatment costs in Germany and the United States (US) from 2011 through 2024.

The database study will use a new-user design to evaluate age- and sex-standardized use of clopidogrel, ticagrelor, and prasugrel initiators among P2Y12 inhibitor initiators over time in separate German and US populations following evolving clinical evidence and guideline recommendations. The 12-month treatment costs for each treatment will be assessed over time. In addition, population-level temporal trends in major adverse cardiovascular events and bleeding-related hospitalizations will be described in Germany in the context of changes in clinical treatment guidelines for P2Y12 inhibitor selection after acute myocardial infarction. In the US, industry payments related to ticagrelor and prasugrel made to healthcare providers will be analyzed. Provider-level prescribing patterns according to receipt of industry payments will be described.

Study Type

Observational

Enrollment (Actual)

377753

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

This study uses a series of descriptive observational analyses conducted using German and US healthcare claims data, the CMS Open Payments database, and Medicare Part D prescribing data by national provider identifier.

Patient-level analyses will use new-user cohort study designs conducted separately in German and US administrative healthcare claims databases. These analyses will evaluate temporal trends in the age- and sex-standardized initiation of clopidogrel, ticagrelor, and prasugrel among adults initiating outpatient P2Y12 inhibitor therapy after acute myocardial infarction and describe these trends in the context of the evolving evidence base and guideline recommendations. In addition, patient-level analyses will assess temporal trends in 12-month treatment costs, as well as population-level trends in major adverse cardiovascular events and bleeding-related hospitalizations among P2Y12 inhibitor initiators in Germany.

Separate US-based analyses will evaluate industry payments associated with ticagrelor and prasugrel reported in the CMS Open Payments database and provider-level prescribing patterns according to receipt of ticagrelor-associated industry payments using linked Medicare Part D prescribing data.

Eligible cohort entry dates for patient-level analyses will range from 2011 through 2024.

PATIENT-LEVEL COHORT ANALYSES Inclusion Criteria

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

Exclusion Criteria

  • 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

  • US Medicare Part D providers
  • >10 ticagrelor or prasugrel claims during both the baseline period (2020-2021) and outcome period (2022-2023).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initiators of clopidogrel
Exposure group
Drug: Clopidogrel
Initiation of clopidogrel in healthcare claims is used as the exposure.
Initiators of prasugrel
Exposure group
Drug: Prasugrel
Initiation of prasugrel in healthcare claims is used as the exposure.
Initiators of ticagrelor
Exposure group
Drug: Ticagrelor
Initiation of ticagrelor in healthcare claims is used as the exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Population-level trends in age- and sex-standardized proportions of clopidogrel, ticagrelor, and prasugrel initiators over time
Time Frame: 2011 to 2024
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
Time Frame: 2011 to 2024
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated population-level drug cost savings associated with replacement of ticagrelor with prasugrel in clinical practice in the US
Time Frame: Q4 2019 to Q4 2024
To evaluate the potential drug cost savings associated with replacing ticagrelor with prasugrel in the US following evidence supporting prasugrel's superiority.
Q4 2019 to Q4 2024
Cumulative general and research industry payments associated with ticagrelor and prasugrel from 2013 onward
Time Frame: 2013 to 2024
To evaluate temporal trends in industry payments associated with ticagrelor and prasugrel reported in the CMS Open Payments database between 2013 and 2024.
2013 to 2024
Ticagrelor prescribing share among combined ticagrelor and prasugrel claims during outcome years (2022-2023), categorized as low (<20%), medium (20-80%), and high (>80%)
Time Frame: Baseline years: 2020-2021; outcome years: 2022-2023
To evaluate the association between ticagrelor-associated industry payments received by US providers in 2020 and 2021 and subsequent ticagrelor prescribing patterns among ticagrelor and prasugrel prescribers in 2022 and 2023.
Baseline years: 2020-2021; outcome years: 2022-2023
Population-level trends in age- and sex-standardized 1-year cumulative incidence of MACE over time
Time Frame: 1 day after cohort entry date until the first of outcome, disenrollment, 365 days after cohort entry.
To evaluate temporal trends in age- and sex-standardized 1-year risks of major adverse cardiovascular event (MACE, defined as a composite of mortality, acute myocardial infarction, and stroke) among adults initiating outpatient P2Y12 inhibitor therapy after acute myocardial infarction in Germany between 2011 and 2023.
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
Time Frame: 1 day after cohort entry date until the first of outcome, disenrollment, 365 days after cohort entry.
To evaluate temporal trends in age- and sex-standardized 1-year risks of bleeding-related hospitalizations among adults initiating outpatient P2Y12 inhibitor therapy after acute myocardial infarction in Germany between 2011 and 2023.
1 day after cohort entry date until the first of outcome, disenrollment, 365 days after cohort entry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Nils Kruger, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2Y12-Inhibitor-Use-and-Costs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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