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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Marina Pieri, MD
pieri.marina@hsr.it
0039 0226437722
Backup
Luca Baldetti, MD
baldetti.luca@hsr.it
0039 0226437722
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: 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.
Sponsors
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov