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

NCT05774431 | Completed DMC

• 1 other identifier: AZ-DAPT
• Study Type: observational
• Target: 6,789
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Secondary Outcomes (1)

• Proportion of Patients Receiving ASS and Ticagrelor: Comparison to Eligible Group and Description of Antithrombotic Treatment in Study Cohort

  24 months

Interventions

There was no intervention necessary. OTHER

There was no intervention necessary.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• Patients over 18 years old
• Clinical symptoms of acute coronary syndrome

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospital of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (2)

• 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.

  PMID: 40227426 DERIVED

• Yildirim 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.

  PMID: 37581388 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: March 13, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)