PLT-ECMO: Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

Sponsor

University of Milano Bicocca (Other)

Overall Status

Recruiting

CT.gov ID

NCT05730114

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Myocardial Infarction Extracorporeal Membrane Oxygenation Platelet Dysfunction	Drug: Antiplatelet Drug

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
OHCA/ECMO Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and on VA-ECMO.	Drug: Antiplatelet 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.	Drug: Antiplatelet 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.	Drug: Antiplatelet Drug anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.

Arm

Intervention/Treatment

OHCA/ECMO

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

Drug: Antiplatelet 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.

Drug: Antiplatelet 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.

Drug: Antiplatelet Drug

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS San Gerardo dei Tintori	Monza	MB	Italy	20900

Sponsors and Collaborators

University of Milano Bicocca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matteo Pozzi, MD, University of Milano Bicocca

ClinicalTrials.gov Identifier:

NCT05730114

Other Study ID Numbers:

3940

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Heart Arrest

Infarction

Platelet Aggregation Inhibitors

Study Results

No Results Posted as of Feb 15, 2023