Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

NCT05730114 | Unknown

• 1 other identifier: 3940
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HRPR risk

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

  7 days

Study Arms (3)

OHCA/ECMO

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

Drug: Antiplatelet Drug

OHCA/nonECMO

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

Drug: Antiplatelet Drug

nonOHCA/nonECMO

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

Drug: Antiplatelet Drug

Interventions

Antiplatelet Drug DRUG

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

OHCA/ECMO; OHCA/nonECMO; nonOHCA/nonECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient admitted to ICU for Acute Coronary Syndrome and treated with oral P2Y12 inhibitors during primary PCI.

You may qualify if:

• Patients P2Y12 naive
• Suffering from Acute Coronary Syndrome needing primary percutaneous coronary intervention (PCI) and treated with oral antiP2Y12 drugs

You may not qualify if:

• Known liver or hematological disease
• Anticoagulant therapy
• Active bleeding needing blood transfusions.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Myocardial Infarction

Interventions

Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Matteo Pozzi, MD

CONTACT

00390392334330; mateo.pozzi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

IT (1)