Disparities in the Proportion of Ticagrelor and Prasugrel-eligible Patients With Acute Coronary Syndrome in a Real-world Registry

Overview

Our primary objective is to compare patients who are eligible for ASS and Ticagrelor against those who are eligible for ASS and Prasugrel. Reasons for disqualification for either drug is outlined based on available information regarding relative and absolute exclusion criteria. Our secondary objectives are to assess 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.

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: September 30, 2023

Detailed Description

In this retrospective single center study at University Hospital of Heidelberg, we will consecutively screen all patients with suspected ACS between in a 24-month period. Patients are managed in a chest pain unit (CPU), which represents a specialized ED that is led by a cardiologist and requires certification by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie; DGK). In Germany, more than 320 certified CPUs are distributed across the country and represent the preferred facilities for the evaluation of patients with suspected ACS. Details on the CPU organization and certification requirements have been published earlier. The ED is under the permanent supervision of a senior cardiologist who is responsible for the decision to admit or discharge, for the selection of antiplatelet and antithrombotic drugs, and for the indication and timing of an invasive strategy. All patients will undergo a clinical assessment that included 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 will be 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. While 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 and all decision for adjunctive pharmacological treatments are left to the discretion of the invasive cardiologist before transferred 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. Confirmation of ED diagnoses for research purposes will be done retrospectively by two cardiologists and a third cardiologist in case of discordance. For the purpose of the present evaluation, 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 published earlier.

Interventions

• Other: There was no intervention necessary.
  • There was no intervention necessary.

Clinical Trial Outcome Measures

Primary Measures

• Comparison of DAPT
  • Time Frame: 24 months
  • Comparing patients who are eligible for ASS and Ticagrelor against those who are eligible for ASS and Prasugrel

Secondary Measures

• Assessing anti thrombotic therapy
  • Time Frame: 24 months
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

• Patients over 18 years old – Clinical symptoms of acute coronary syndrome Exclusion Criteria:

• hemodialysis – Atrial tachycardia with accompanying symptoms, but without clinical suspicion of an ACS (Acute Coronary Syndrome).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

• Lead Sponsor
  • University Hospital Heidelberg
• Collaborator
  • AstraZeneca
• Provider of Information About this Clinical Study
  • Principal Investigator: Mustafa Yildirim, Dr. med. univ. Mustafa Yildirim – University Hospital Heidelberg