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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05730114
Other study ID # 3940
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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