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Studies

Interventional Recruiting Phase 2

NCT06792643 on ClinicalTrials.gov

Cangrelor on Top of AnticoagUlation in Patients with MyocaRdial Infarction-related Cardiogenic Shock/Cardiac Arrest ReceiVIng VA-ECMO

Official title: 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

  • Sponsor: IRCCS Ospedale San Raffaele
  • Enrollment: 50 (Estimated)
  • Study start: 2024-04-01 (Actual)
  • Primary completion: 2025-10-29 (Estimated)
  • Study completion: 2025-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Cardiogenic Shock
  • Extracorporeal Membrane Oxygenation Complication
  • Platelet Dysfunction

Intervention / Treatment

  • Drug: Cangrelor

Primary Outcome Measures

  • Major bleeding [type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding] - Safety outcome (Up to 48 hours after ECMO support withdrawal)
    Major bleeding will be defined as type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding.
  • Thrombotic events - Efficacy outcome (Up to 48 hours after ECMO support withdrawal)
    Thrombotic events will be defined as: any new myocardial infarction, any definite or probable stent thrombosis (ST) according to Academic Research Consortium (ARC)-2 criteria, any peripheral arterial thrombosis, any venous thrombosis/venous thromboembolism or imaging-defined ischemic stroke.
  • Multiplate assay with ADP-test values <46 U (Up to 48 hours after ECMO support withdrawal)
    Multiplate assay with ADP-test values \<46 U (time in therapeutic range)

Countries

Italy

Locations and Investigators

  • IRCCS San Raffaele Hospital, Milan, Italy (Recruiting)