Cangrelor: Cangrelor will be started without bolus at a low dose of 0.125 mcg/kg/min and titrated (by 0.125 mcg/kg/min steps) based on the results of platelet function assay to guarantee effective platelet P2Y12 pathway inhibition.
Study summary
The SURVIVE trial aims to test whether using an anti-thrombotic regimen involving cangrelor can reduce bleeding risk while maintaining effective antithrombotic effects in patients on VA-ECMO due to cardiogenic shock (CS)/ cardiac arrest (CA) who undergo percutaneous coronary intervention (PCI). The investigators plan to achieve this by starting cangrelor on top of systemic anticoagulation with bivalirudin at a low dose, regularly monitoring platelet function, and adjusting the dose based on the results of platelet function assay (Multiplate®) to guarantee effective platelet P2Y12 pathway inhibition to achieve optimal platelet inhibition. Platelet function assays will be performed at various time points throughout the treatment timeframe. Cangrelor will then be stopped at the end of VA-ECMO support, and patients will be transitioned to oral P2Y12- inhibitors as per clinical guidelines.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female patients aged ≥18 years;
* ACS-related CS/CA patients undergoing PCI (either with or without stent implantation) and needing VA-ECMO support;
* Patients who received pre-hospital aspirin intravenous loading dose or patients naïve to any anti-thrombotic agent;
* Written informed consent
Exclusion Criteria:
* Overt uncontrollable bleeding;
* Suspected intra-cranial haemorrhage;
* Patients who received any dose of any oral P2Y12-inhibitors;
* Patients with known history of stroke or Transient Ischaemic Attack (TIA);
* Patients with known hypersensitivity to the active substance (cangrelor) or to any of its excipients;
* Pregnancy.
Primary outcome measure(s)
Major bleeding [type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding] - Safety outcome — Up to 48 hours after ECMO support withdrawal Major bleeding will be defined as type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding.
Thrombotic events - Efficacy outcome — Up to 48 hours after ECMO support withdrawal Thrombotic events will be defined as: any new myocardial infarction, any definite or probable stent thrombosis (ST) according to Academic Research Consortium (ARC)-2 criteria, any peripheral arterial thrombosis, any venous thrombosis/venous thromboembolism or imaging-defined ischemic stroke.
Multiplate assay with ADP-test values <46 U — Up to 48 hours after ECMO support withdrawal Multiplate assay with ADP-test values \<46 U (time in therapeutic range)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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