Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

Recruiting

• Conditions: Myocardial Infarction; Cardiac Arrest; Extracorporeal Membrane Oxygenation; Platelet Dysfunction
• Interventions: Drug: Antiplatelet Drug

• Registration Number: NCT05730114
• Lead Sponsor: University of Milano Bicocca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OHCA/ECMO	Antiplatelet Drug	Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and on VA-ECMO.
OHCA/nonECMO	Antiplatelet Drug	Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO.
nonOHCA/nonECMO	Antiplatelet Drug	Patient with acute coronary syndrome without Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO.

Primary Outcome Measures

Name	Time	Method
HRPR risk	7 days	Relative risk to develop High Residual Platelet Reactivity (HRPR) during the first seven days of treatment.

Trial Locations

Locations (1)

IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, MB, Italy