Cangrelor on Top of anticoagUlation in Patients With myocaRdial Infarction-related Cardiogenic Shock/Cardiac Arrest receiVIng VA-ECMO
Efficacy and Safety of Cangrelor on Top of anticoagUlation in Patients With myocaRdial Infarction Related Cardiogenic Shock/Cardiac Arrest receiVIng VAECMO Support - a Phase 2, Single Arm, Single Center Trial
IRCCS San Raffaele
50 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06792643