Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06792643

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele Hospital

Milan, Italy, Italy, 20132

Actively Recruiting

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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

Frequently Asked Questions

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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 | DecenTrialz