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

NCT06792643 | Recruiting Phase 2

• 1 other identifier: SURVIVE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Cangrelor; ACS; Cardiogenic Shock; PCI; ECMO; VA-EMO; Acute coronary syndrome; P2Y12; Anti-thrombotic therapy; Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 48 hours after ECMO support withdrawal

• 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.

  Up to 48 hours after ECMO support withdrawal

• Multiplate assay with ADP-test values <46 U

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

  Up to 48 hours after ECMO support withdrawal

Study Arms (1)

Cangrelor

EXPERIMENTAL

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.

Drug: Cangrelor

Interventions

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.

Cangrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);
• Patients with known hypersensitivity to the active substance (cangrelor) or to any of its excipients;
• Pregnancy.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Acute Coronary Syndrome

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Marina Pieri, MD

CONTACT

0039 0226437722; pieri.marina@hsr.it

Luca Baldetti, MD

CONTACT

0039 0226437722; baldetti.luca@hsr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 27, 2025
• Study Start: April 1, 2024
• Primary Completion: October 29, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)