Actively Recruiting
Efficacy and Safety of Cangrelor on Top of Anticoagulation in Patients 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
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Patients with acute coronary syndrome-related cardiogenic shock or cardiac arrest undergoing PCI and requiring VA-ECMO support
- Patients who received pre-hospital intravenous aspirin or are new to any antithrombotic agents
- Written informed consent provided
You will not qualify if you...
- Uncontrollable bleeding
- Suspected intracranial hemorrhage
- Prior use of any oral P2Y12 inhibitors
- History of stroke or transient ischemic attack (TIA)
- Known allergy to cangrelor or its components
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are evaluated for conditions including cardiogenic shock or cardiac arrest related to acute coronary syndrome and suitability for VA-ECMO support.
Duration - Duration of VA-ECMO support
Participants receive cangrelor, an intravenous antiplatelet drug, started at a low dose and adjusted based on platelet function tests while on VA-ECMO support and after PCI.
Regular platelet function assessments including baseline, 30 minutes after infusion start, 12 hours after, after dose changes, daily, and during bleeding or thrombotic events
Duration - Up to 48 hours after VA-ECMO support withdrawal
Participants are monitored for safety and efficacy outcomes including bleeding events, thrombotic events, and platelet function up to 48 hours after VA-ECMO support ends.
Visits or assessments occur up to 48 hours post-treatment
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Hospital
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
M
Marina Pieri, MD
L
Luca Baldetti, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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