NCT06792643 Cangrelor on Top of anticoagUlation in Patients With myocaRdial Infarction-related Cardiogenic Shock/Cardiac Arrest receiVIng VA-ECMO
| NCT ID | NCT06792643 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | IRCCS San Raffaele |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-04-01 with a primary completion date of 2025-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06792643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06792643 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06792643 currently recruiting?
Yes, NCT06792643 is actively recruiting participants. Contact the research team at pieri.marina@hsr.it for enrollment information.
Where is the NCT06792643 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06792643 clinical trial?
NCT06792643 is sponsored by IRCCS San Raffaele. The trial plans to enroll 50 participants.