Cangrelor on Top of anticoagUlation in Patients With myocaRdial Infarction-related Cardiogenic Shock/Cardiac Arrest receiVIng VA-ECMO

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Overt uncontrollable bleeding;

Suspected intra-cranial haemorrhage;

Patients who received any dose of any oral P2Y12-inhibitors;

Patients with known history of stroke or Transient Ischaemic Attack (TIA);

Trial design

Design model

Single group

Treatments tested in this trial

  • Cangrelor

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: CangrelorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major bleeding [type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding] - Safety outcome

Major bleeding will be defined as type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding.

Time frame
Up to 48 hours after ECMO support withdrawal
2

Thrombotic events - Efficacy outcome

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.

Time frame
Up to 48 hours after ECMO support withdrawal
3

Multiplate assay with ADP-test values <46 U

Multiplate assay with ADP-test values \<46 U (time in therapeutic range)

Time frame
Up to 48 hours after ECMO support withdrawal

Secondary outcomes

Other outcomes

Sponsors and contacts

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