Actively Recruiting
Cangrelor With Anticoagulation for Patients with Heart Attack-Related Cardiogenic Shock or Cardiac Arrest Receiving VA-ECMO Support A Phase 2 Single-Center Trial Evaluating Safety and Efficacy
Led by IRCCS San Raffaele · Updated on 2025-01-27
50
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding cangrelor to standard anticoagulation can reduce bleeding risks while ensuring 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 support creates a complex balance between blood clotting and bleeding risks. Current antithrombotic treatments may increase bleeding, so this study tests a new approach using cangrelor, an intravenous drug with rapid on and off effects, to optimize platelet inhibition safely. Participants will receive systemic anticoagulation with bivalirudin adjusted to maintain an activated thromboplastin time of 55-70 seconds. Cangrelor will be started at a low dose without a bolus and adjusted based on platelet function tests using the Multiplate analyzer targeting a specific platelet inhibition level (ADP-test <46 U). Platelet function will be monitored regularly at baseline, during treatment, after dose changes, and following any bleeding or clotting events. Cangrelor treatment will stop when VA-ECMO support ends, and patients will then switch to oral P2Y12 inhibitors as per clinical guidelines. During the study, participants will undergo multiple platelet function assessments and be monitored for bleeding events, clotting complications, and overall safety up to 48 hours after stopping VA-ECMO. The primary outcomes include the rate of major bleeding and thrombotic events during this period. This phase 2, single-arm study will provide data on the balance of bleeding and clotting risks using cangrelor on top of anticoagulation in this critical patient group.
CONDITIONS
Official 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
- Patients with acute coronary syndrome-related cardiogenic shock or cardiac arrest undergoing percutaneous coronary intervention with or without stent implantation and requiring VA-ECMO support
- Patients who have received pre-hospital intravenous aspirin loading or are naive to any antithrombotic agent
- Written informed consent provided
You will not qualify if you...
- Uncontrolled bleeding
- Suspected intracranial hemorrhage
- Prior use of any oral P2Y12 inhibitors
- Known history of stroke or transient ischemic attack (TIA)
- Known allergy to cangrelor or its components
- Pregnancy
AI-Screening
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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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