Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES). CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.

Official Title
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Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT

Conditions
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Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug-Eluting Stents

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presentation with acute coronary syndrome (ACS) Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion Exclusion Criteria: Known pregnancy Life expectancy less than one year Planned elective surgery requiring interruption of DAPT in the first 6 months Known intolerance to components of the DES available Indication for oral anticoagulation at baseline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clopidogrel Period<br>ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen | Drug: Clopidogrel<br> <br> * Other names: Plavix;|
| Ticagrelor Period<br>ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen | Drug: Ticagrelor<br> <br> * Other names: Brilique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical and cerebral events (NACCE) | A composite of all-cause death, any myocardial infarction, stroke, or major bleeding. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | All-cause mortality | 1 year | 
| Any myocardial infarction | According to the Academic Research Consortium (ARC) definition | 1 year | 
| Stroke | Focal loss of neurologic function caused by an ischemic or hemorrhagic event with residual symptoms lasting at least 24 hours or leading to death | 1 year | 
| Major Bleeding | Defined by Thrombolysis in Myocardial Infarction (TIMI) major bleeding or TIMI in the setting of coronary artery bypass grafting, and/or any Bleeding Academic Research Consortium (BARC) class 3 or 5. | 1 year | 
| Any clinically indicated revascularization | Revascularization by PCI or CABG | 1 year | 
| Stent thrombosis | According to the Academic Research Consortium (ARC) definition | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug-Eluting Stents, Platelet Aggregation Inhibitors, clopidogrel, Purinergic P2Y Receptor Antagonists