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Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction

2026년 7월 7일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

377753

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02120
        • Brigham and Women's Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Population-level trends in age- and sex-standardized proportions of clopidogrel, ticagrelor, and prasugrel initiators over time
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Estimated population-level drug cost savings associated with replacement of ticagrelor with prasugrel in clinical practice in the US
기간: 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
기간: 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%)
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Nils Krüger, MD, Brigham and Women's Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 1일

기본 완료 (실제)

2026년 5월 31일

연구 완료 (실제)

2026년 5월 31일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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