Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

Myocardial Infarction Clinical Trial

— PLT-ECMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730114
• Other study ID #: 3940
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2023
• Source: University of Milano Bicocca
• Contact: Matteo Pozzi, MD
• Phone: 00390392334330
• Email: mateo.pozzi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Extracorporeal Membrane Oxygenation
• Heart Arrest
• Infarction
• Myocardial Infarction
• Platelet Dysfunction

Intervention

Drug:
• Antiplatelet Drug
anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.

Locations

Country	Name	City	State
Italy	IRCCS San Gerardo dei Tintori	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRPR risk	Relative risk to develop High Residual Platelet Reactivity (HRPR) during the first seven days of treatment.	7 days