Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05774431 |
| Other study ID # |
AZ-DAPT |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2023 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University Hospital Heidelberg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
