Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

NCT ID: NCT05730114

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-30

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.

Conditions

Cardiac Arrest; Myocardial Infarction; Extracorporeal Membrane Oxygenation; Platelet Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OHCA/ECMO

Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and on VA-ECMO.

Antiplatelet Drug

Intervention Type: DRUG

anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.

OHCA/nonECMO

Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO.

Antiplatelet Drug

Intervention Type: DRUG

anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.

nonOHCA/nonECMO

Patient with acute coronary syndrome without Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO.

Antiplatelet Drug

Intervention Type: DRUG

anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.

Interventions

Antiplatelet Drug

anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Matteo Pozzi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS San Gerardo dei Tintori

Monza, MB, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Matteo Pozzi, MD

Role: CONTACT

mateo.pozzi@gmail.com

00390392334330

Facility Contacts

Matteo Pozzi

Role: primary

mateo.pozzi@gmail.com

3477252346

Other Identifiers

3940

Identifier Type: -

Identifier Source: org_study_id