Actively Recruiting
Phase 2 Study of Cangrelor Added to Anticoagulation in Adults With Myocardial Infarction-Related Cardiogenic Shock or Cardiac Arrest Receiving VA-ECMO Support
Led by IRCCS San Raffaele · Updated on 2025-01-27
50
Participants Needed
1
Research Sites
9 weeks
Total Duration
AI-Summary
What this Trial Is About
The trial investigates whether adding the drug cangrelor to low-dose bivalirudin anticoagulation can lower bleeding risk while maintaining effective antithrombotic protection in patients on Veno-Arterial Extracorporeal Membrane Oxygenation VA-ECMO due to cardiogenic shock or cardiac arrest who undergo percutaneous coronary intervention PCI. VA-ECMO is used in severe heart failure and cardiac arrest cases but creates a complex balance of blood clotting and bleeding risks. The study aims to find the best antithrombotic treatment for these patients, as current therapies may increase bleeding complications. Participants will receive cangrelor starting at a low dose without an initial bolus, with doses adjusted based on platelet function tests Multiplate analyzer to ensure proper platelet inhibition. Systemic anticoagulation with bivalirudin will be given at a dose targeting a specific blood clotting time. Platelet function will be regularly monitored at multiple time points, including before and during treatment, after dose changes, and following any bleeding or clotting events. Cangrelor will be stopped after VA-ECMO support ends, and patients will transition to oral P2Y12 inhibitors according to clinical guidelines. Throughout the study, participants will undergo frequent platelet function assays and monitoring to evaluate bleeding events and thrombotic complications, with safety and efficacy outcomes measured up to 48 hours after ECMO withdrawal. The primary outcomes include major bleeding events, thrombotic events, and effective platelet inhibition as indicated by specific platelet test values. The study is a phase 2, single-arm trial assessing these outcomes in patients receiving this treatment regimen.
CONDITIONS
Brief Title
Cangrelor on Top of anticoagUlation in Patients With myocaRdial Infarction-related Cardiogenic Shock/Cardiac Arrest receiVIng VA-ECMO
Research Team
M
Marina Pieri, MD
L
Luca Baldetti, MD
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