- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07610577
Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02120
- Brigham and Women's Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Population-level trends in age- and sex-standardized proportions of clopidogrel, ticagrelor, and prasugrel initiators over time
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Estimated population-level drug cost savings associated with replacement of ticagrelor with prasugrel in clinical practice in the US
Zeitfenster: 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
Zeitfenster: 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%)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nils Krüger, MD, Brigham and Women's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Herzkrankheiten
- Infarkt
- Nekrose
- Myokardischämie
- Ischämie
- Pathologische Zustände, Anzeichen und Symptome
- Herzinfarkt
- Schwefelverbindungen
- Organische Chemikalien
- Pyridinen
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Nukleinsäuren, Nukleotide und Nukleoside
- Purines
- Nukleoside
- Ribonukleoside
- Thiophenes
- Adenosin
- Purin -Nukleoside
- Piperazines
- Ticlopidin
- Thienopyridiner
- Ticagrelor
- Clopidogrel
- Prasugrelhydrochlorid
Andere Studien-ID-Nummern
- P2Y12-Inhibitor-Use-and-Costs
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .