Acute Myocardial InfarctionAZ-DAPTNCT05774431
Disparities in the Proportion of Ticagrelor and Prasugrel-eligible Patients with Acute Coronary Syndrome in a Real-world Registry
An observational study of Acute Myocardial Infarction, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The primary objective of this study is to compare patients eligible for ASS and Ticagrelor against those eligible for ASS and Prasugrel. The available information regarding relative and absolute exclusion criteria outlines reasons for disqualification from either drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 6,789 participants
- Where
- 1 siteGermany
- Study dates
- 13 Mar 2023to 30 Dec 2024
- 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: In this retrospective single center study, we will consecutively screen all patients with suspected acute coronary syndrome presenting to the Chest Pain Unit (CPU) of the University Hospital of Heidelberg between 1st of July 2016 and 30th of June 2018. Patients will be managed in CPU, which represents a specialized emergency department (ED) that is led by a cardiologist and requires certification by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie; DGK).
Who may be able to join
- Patients over 18 years old
- Clinical symptoms of acute coronary syndrome
Who cannot join
- hemodialysis
- Atrial tachycardia with accompanying symptoms, but without clinical suspicion of an ACS (Acute Coronary Syndrome).
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
The primary objective of this study is to compare patients eligible for ASS and Ticagrelor against those eligible for ASS and Prasugrel. The available information regarding relative and absolute exclusion criteria outlines reasons for disqualification from either drug.
The secondary objectives of the study are to:
Read more
- Assess the proportion of patients who received ASS and Ticagrelor in the study cohort.
- Compare the proportion of patients who received ASS and Ticagrelor against the proportion of patients who qualify for DAPT with ASS and Ticagrelor (eligible group).
- Describe the antithrombotic treatment, including antiplatelet monotherapies, and antiplatelet therapies with or without anticoagulation.
The investigators will use these objectives to evaluate the effectiveness and appropriateness of the different antiplatelet therapies in the study population. Participants will not be personally identified in any reports or publications resulting from this study.
Read the detailed description
This retrospective single-center study at University Hospital of Heidelberg aims to consecutively screen all patients with suspected ACS over a 24-month period. Patients will be managed in a chest pain unit (CPU), which is a specialized ED led by a cardiologist and requires certification by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie; DGK). More than 320 certified CPUs are distributed across Germany and represent the preferred facilities for evaluating patients with suspected ACS. CPU organization and certification requirements have been previously published.
The ED is under the supervision of a senior cardiologist who is responsible for decisions regarding admission or discharge, selection of antiplatelet and antithrombotic drugs, and indication and timing of an invasive strategy. All patients will undergo a clinical assessment, including medical history, physical examination, 12-lead ECG, continuous ECG monitoring, pulse oximetry, and standard blood tests. The standard 12-lead ECG includes routinely precordial leads V7-V9. Results will be reported on the electronic patient record and communicated to the clinicians responsible for patient care.
There is unlimited access to coronary angiography or other diagnostic resources as per the required criteria for certification of a CPU. Although STEMI patients were not excluded from the analysis, patients with qualifying ST-segment elevations or a presumably new bundle branch block were primarily seen in the catheterization laboratory bypassing the ED. All decisions for adjunctive pharmacological treatments are left to the discretion of the invasive cardiologist before transfer back for observation to the coronary care ward or to the ED.
Acute myocardial infarction (MI) will be diagnosed in-hospital by treating clinicians based on all clinical information, using the diagnostic criteria of the 3rd or 4th universal MI definition. For research purposes, two cardiologists will retrospectively confirm ED diagnoses, with a third cardiologist consulted in case of discordance. All files of patients with confirmed ACS will be screened for information on body weight, pretreatment with P2Y12-Inhibitors before hospital admission, pre-treatment with oral anticoagulants before index admission, or new requirement for oral anticoagulation. Data on age, selection of antiplatelet drugs, invasive strategy including rates of coronary angiography, PCI, CABG, a planned conservative, or conservative therapy in the case of complex coronary angiography or failed PCI were already collected in the electronic registry database, and findings from this registry have been previously published.
- Conditions
- Acute Myocardial Infarction
- Being tested
- There was no intervention necessary.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There was no intervention necessary.Other
There was no intervention necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Eligible Patients for Dual Antiplatelet Therapy: ASS and Ticagrelor vs ASS and Prasugrel
Comparing patients who are eligible for ASS and Ticagrelor against those who are eligible for ASS and Prasugrel
Measured: 24 months
Secondary outcomes (1)
Proportion of Patients Receiving ASS and Ticagrelor: Comparison to Eligible Group and Description of Antithrombotic Treatment in Study Cohort
Assessing the proportion of patients who received ASS and Ticagrelor in the study cohort, to compare the proportion of patients who received ASS and Ticagrelor against the proportion of patients who qualify for DAPT with ASS and Ticagrelor (eligible group) and to describe the antithrombotic treatment, i.e. antiplatelet monotherapies, antiplatelet therapies with or without anticoagulation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start13 Mar 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- 6,789 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Mustafa Yildirim, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774431
- Sponsor's protocol ID
- AZ-DAPT
- Acronym
- AZ-DAPT
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildirim M, Reich C, Salbach C, Biener M, Mueller-Hennessen M, Sorensen NA, Haller PM, Blankenberg S, Neumann JT, Twerenbold R, Frey N, Giannitsis E. Identification of patients with suspected NSTE-ACS in the observe zone: evaluating GRACE 1.0 score and a biomarker panel for risk stratification and management optimization. Clin Res Cardiol. 2025 Jun;114(6):783-795. doi: 10.1007/s00392-025-02642-3. Epub 2025 Apr 14.
PubMed 40227426Yildirim M, Mueller-Hennessen M, Milles BR, Biener M, Hund H, Frey N, Giannitsis E, Salbach C. Real-World Evidence on Disparities on the Initiation of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2023 Aug 15;12(16):e030879. doi: 10.1161/JAHA.123.030879. Epub 2023 Aug 10.
PubMed 37581388
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparities in the Proportion of Ticagrelor and Prasugrel-eligible Patients with Acute Coronary Syndrome in a Real-world Registry
- ClinicalTrials.gov ID
- NCT05774431
- Acronym / sponsor ID
- AZ-DAPT / AZ-DAPT
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,789 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 17 Mar 2023 (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.
The primary objective of this study is to compare patients eligible for ASS and Ticagrelor against those eligible for ASS and Prasugrel. The available information regarding relative and absolute exclusion criteria outlines reasons for disqualification from either drug.
The secondary objectives of the study are to:
- Assess the proportion of patients who received ASS and Ticagrelor in the study cohort.
- Compare the proportion of patients who received ASS and Ticagrelor against the proportion of patients who qualify for DAPT with ASS and Ticagrelor (eligible group).
- Describe the antithrombotic treatment, including antiplatelet monotherapies, and antiplatelet therapies with or without anticoagulation.
The investigators will use these objectives to evaluate the effectiveness and appropriateness of the different antiplatelet therapies in the study population. Participants will not be personally identified in any reports or publications resulting from this study.
Detailed description
This retrospective single-center study at University Hospital of Heidelberg aims to consecutively screen all patients with suspected ACS over a 24-month period. Patients will be managed in a chest pain unit (CPU), which is a specialized ED led by a cardiologist and requires certification by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie; DGK). More than 320 certified CPUs are distributed across Germany and represent the preferred facilities for evaluating patients with suspected ACS. CPU organization and certification requirements have been previously published.
The ED is under the supervision of a senior cardiologist who is responsible for decisions regarding admission or discharge, selection of antiplatelet and antithrombotic drugs, and indication and timing of an invasive strategy. All patients will undergo a clinical assessment, including medical history, physical examination, 12-lead ECG, continuous ECG monitoring, pulse oximetry, and standard blood tests. The standard 12-lead ECG includes routinely precordial leads V7-V9. Results will be reported on the electronic patient record and communicated to the clinicians responsible for patient care.
There is unlimited access to coronary angiography or other diagnostic resources as per the required criteria for certification of a CPU. Although STEMI patients were not excluded from the analysis, patients with qualifying ST-segment elevations or a presumably new bundle branch block were primarily seen in the catheterization laboratory bypassing the ED. All decisions for adjunctive pharmacological treatments are left to the discretion of the invasive cardiologist before transfer back for observation to the coronary care ward or to the ED.
Acute myocardial infarction (MI) will be diagnosed in-hospital by treating clinicians based on all clinical information, using the diagnostic criteria of the 3rd or 4th universal MI definition. For research purposes, two cardiologists will retrospectively confirm ED diagnoses, with a third cardiologist consulted in case of discordance. All files of patients with confirmed ACS will be screened for information on body weight, pretreatment with P2Y12-Inhibitors before hospital admission, pre-treatment with oral anticoagulants before index admission, or new requirement for oral anticoagulation. Data on age, selection of antiplatelet drugs, invasive strategy including rates of coronary angiography, PCI, CABG, a planned conservative, or conservative therapy in the case of complex coronary angiography or failed PCI were already collected in the electronic registry database, and findings from this registry have been previously published.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this retrospective single center study, we will consecutively screen all patients with suspected acute coronary syndrome presenting to the Chest Pain Unit (CPU) of the University Hospital of Heidelberg between 1st of July 2016 and 30th of June 2018. Patients will be managed in CPU, which represents a specialized emergency department (ED) that is led by a cardiologist and requires certification by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie; DGK).
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Clinical symptoms of acute coronary syndrome
Key exclusion criteria (2 listed)
- hemodialysis
- Atrial tachycardia with accompanying symptoms, but without clinical suspicion of an ACS (Acute Coronary Syndrome).
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 |
|---|---|---|
| There was no intervention necessary.There was no intervention necessary. | Other | – |
Primary outcome
Comparison of Eligible Patients for Dual Antiplatelet Therapy: ASS and Ticagrelor vs ASS and Prasugrel
Time frame: 24 months
Comparing patients who are eligible for ASS and Ticagrelor against those who are eligible for ASS and Prasugrel
1 secondary outcome
Proportion of Patients Receiving ASS and Ticagrelor: Comparison to Eligible Group and Description of Antithrombotic Treatment in Study Cohort
Time frame: 24 months
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 30 Mar 2025.
- Derived from this study: PubMed 40227426Yildirim M, Reich C, Salbach C, Biener M, Mueller-Hennessen M, Sorensen NA, Haller PM, Blankenberg S, Neumann JT, Twerenbold R, Frey N, Giannitsis E. Identification of patients with suspected NSTE-ACS in the observe zone: evaluating GRACE 1.0 score and a biomarker panel for risk stratification and management optimization. Clin Res Cardiol. 2025 Jun;114(6):783-795. doi: 10.1007/s00392-025-02642-3. Epub 2025 Apr 14.
- Derived from this study: PubMed 37581388Yildirim M, Mueller-Hennessen M, Milles BR, Biener M, Hund H, Frey N, Giannitsis E, Salbach C. Real-World Evidence on Disparities on the Initiation of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2023 Aug 15;12(16):e030879. doi: 10.1161/JAHA.123.030879. Epub 2023 Aug 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University Hospital Heidelberg at 1 site in Germany.
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 2 inclusion and 2 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 30 Mar 2025. 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 Germany. 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?
Comparison of Eligible Patients for Dual Antiplatelet Therapy: ASS and Ticagrelor vs ASS and Prasugrel (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774431, which also lists 2 linked publications.
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 30 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.