Using cangrelor to improve outcomes in patients with cardiogenic shock on ECMO
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
This study is testing if adding a medication called cangrelor can help patients in cardiogenic shock on ECMO have better outcomes while reducing bleeding risks during their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06792643 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of cangrelor, an anti-thrombotic medication, in patients experiencing cardiogenic shock or cardiac arrest who are receiving veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and undergoing percutaneous coronary intervention (PCI). The approach involves administering cangrelor alongside a low dose of bivalirudin, with regular monitoring of platelet function to ensure effective inhibition of platelet activity. The goal is to reduce bleeding risks while maintaining adequate antithrombotic effects during this critical treatment phase. Patients will transition to oral P2Y12 inhibitors after the cessation of VA-ECMO support.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute coronary syndrome-related cardiogenic shock or cardiac arrest requiring VA-ECMO support.
Not a fit: Patients with uncontrolled bleeding, suspected intracranial hemorrhage, or those with a history of stroke or TIA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce bleeding complications while ensuring effective platelet inhibition in critically ill patients.
How similar studies have performed: While the specific combination of cangrelor and VA-ECMO is novel, similar studies have shown promise in managing thrombotic risks in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Milan, Italy
- IRCCS San Raffaele Hospital — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Marina Pieri, MD
- Email: pieri.marina@hsr.it
- Phone: 0039 0226437722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.