Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

Study Overview
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Brief Summary
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Dual Antiplatelet Therapy (DAPT) with acetylsalicylic acid (ASA) and oral P2Y12 inhibitor (Clopidogrel, Ticagrelor or Prasugrel) is recommended in STEMI or NSTEMI patients undergoing primary Percutaneous Coronary Intervention (PCI). There is evidence for an increased risk of stent thrombosis after PCI despite administration of DAPT in patients resuscitated from a cardiac arrest with STEMI/NSTEMI who undergo primary PCI, in particular for those treated with hypothermia. Point of Care Aggregometry represents an emerging tool to measure platelet reactivity in patient treated with antiplatelets drugs. Among patients with Acute Coronary Syndrome (ACS), those requiring Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory Cardiogenic Shock or Cardiac Arrest represent a growing population burdened by more profound metabolic, pharmacokinetic, hemostatic and physiological alterations due to increased clinical severity and ECMO itself. In addition, profound platelet inhibition can result in a higher risk of bleeding complication, since these patients have to be simultaneously anticoagulated with unfractioned heparin (UFH) and ECMO itself can cause coagulopathy. We aimed to perform an observational prospective cohort study to investigate platelet reactivity in a population of ACS patients with different clinical severity.

Official Title
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Platelet Aggregation in Patients Treated With P2Y12 Inhibitors and V-A ECMO for Cardiac Arrest

Conditions
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Cardiac Arrest, Myocardial Infarction, Extracorporeal Membrane Oxygenation, Platelet Dysfunction

Intervention / Treatment
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* Drug: Antiplatelet Drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients P2Y12 naive Suffering from Acute Coronary Syndrome needing primary percutaneous coronary intervention (PCI) and treated with oral antiP2Y12 drugs Exclusion Criteria: Known liver or hematological disease Anticoagulant therapy Active bleeding needing blood transfusions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OHCA/ECMO<br>Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and on VA-ECMO. | Drug: Antiplatelet Drug<br>* anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.<br>|
| OHCA/nonECMO<br>Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO. | Drug: Antiplatelet Drug<br>* anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.<br>|
| nonOHCA/nonECMO<br>Patient with acute coronary syndrome without Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO. | Drug: Antiplatelet Drug<br>* anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRPR risk | Relative risk to develop High Residual Platelet Reactivity (HRPR) during the first seven days of treatment. | 7 days |