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Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction

7 lipca 2026 zaktualizowane przez: Nils Krüger, MD, MPH, 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

377753

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02120
        • Brigham and Women's Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Initiators of clopidogrel
Exposure group
Initiation of clopidogrel in healthcare claims is used as the exposure.
Initiators of prasugrel
Exposure group
Initiation of prasugrel in healthcare claims is used as the exposure.
Initiators of ticagrelor
Exposure group
Initiation of ticagrelor in healthcare claims is used as the exposure.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Population-level trends in age- and sex-standardized proportions of clopidogrel, ticagrelor, and prasugrel initiators over time
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Estimated population-level drug cost savings associated with replacement of ticagrelor with prasugrel in clinical practice in the US
Ramy czasowe: 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
Ramy czasowe: 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%)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Nils Krüger, MD, Brigham and Women's Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 listopada 2025

Zakończenie podstawowe (Rzeczywisty)

31 maja 2026

Ukończenie studiów (Rzeczywisty)

31 maja 2026

Daty rejestracji na studia

Pierwszy przesłany

20 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2026

Pierwszy wysłany (Rzeczywisty)

28 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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