Acute Myocardial Infarction (AMI)NCT07610577
Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction (AMI), run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to describe temporal trends in the use and costs of clopidogrel, ticagrelor, and prasugrel in Germany and the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Clopidogrel, Prasugrel and Ticagrelor
- How many people
- 377,753 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged ≥18 years with acute myocardial infarction who initiated outpatient treatment with clopidogrel, ticagrelor, or prasugrel.
Who may be able to join
- Adults aged ≥18 years
- Acute myocardial infarction
- Initiation of outpatient treatment with clopidogrel, ticagrelor, or prasugrel
Who cannot join
- 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
Show all 17Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
This study aims to describe temporal trends in the use and costs of clopidogrel, ticagrelor, and prasugrel in Germany and the United States.
Read the 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.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Clopidogrel, Prasugrel, Ticagrelor
- Keywords
- Acute myocardial infarction, AMI, Myocardial infarction, MI, Ticagrelor, Prasugrel, Clopidogrel, Evidence
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Initiation of clopidogrel in healthcare claims is used as the exposure.
PrasugrelDrug
Initiation of prasugrel in healthcare claims is used as the exposure.
TicagrelorDrug
Initiation of ticagrelor in healthcare claims is used as the exposure.
| Study group | Role | What they receive |
|---|---|---|
| Initiators of clopidogrel | Exposure group Receives: Drug: Clopidogrel | |
| Initiators of prasugrel | Exposure group Receives: Drug: Prasugrel | |
| Initiators of ticagrelor | Exposure group Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2011 to 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Nov 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 377,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Krüger, MD, MPH, Brigham and Women's Hospital
- Investigators
- Nils Kruger, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610577
- Sponsor's protocol ID
- P2Y12-Inhibitor-Use-and-Costs
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Costs of P2Y12 Inhibitors After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07610577
- Acronym / sponsor ID
- P2Y12-Inhibitor-Use-and-Costs
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Acute myocardial infarction, AMI, Myocardial infarction, MI, Ticagrelor, Prasugrel, Clopidogrel, Evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377,753 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to describe temporal trends in the use and costs of clopidogrel, ticagrelor, and prasugrel in Germany and the United States.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Initiators of clopidogrel | – | Drug: ClopidogrelExposure group |
| Initiators of prasugrel | – | Drug: PrasugrelExposure group |
| Initiators of ticagrelor | – | Drug: TicagrelorExposure group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged ≥18 years with acute myocardial infarction who initiated outpatient treatment with clopidogrel, ticagrelor, or prasugrel.
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Acute myocardial infarction
- Initiation of outpatient treatment with clopidogrel, ticagrelor, or prasugrel
Key exclusion criteria (17 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelInitiation of clopidogrel in healthcare claims is used as the exposure. | Drug | Initiators of clopidogrel |
| PrasugrelInitiation of prasugrel in healthcare claims is used as the exposure. | Drug | Initiators of prasugrel |
| TicagrelorInitiation of ticagrelor in healthcare claims is used as the exposure. | Drug | Initiators of ticagrelor |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Kruger, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction (AMI), run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population-level trends in age- and sex-standardized proportions of clopidogrel, ticagrelor, and prasugrel initiators over time (time frame: 2011 to 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.