NCT06792643RecruitingPhase 2
Cangrelor on Top of anticoagUlation in Patients With myocaRdial Infarction-related Cardiogenic Shock/Cardiac Arrest receiVIng VA-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
Source: ClinicalTrials.gov · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Oct 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 29 Oct 2025
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Coronary artery disease
- NCT number
- NCT06792643
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Apr 2024 to the primary completion date, 29 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received any dose of any oral P2Y12-inhibitors;
Other illness
- Overt uncontrollable bleeding;
- Suspected intra-cranial haemorrhage;
- 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;
Other
- Pregnancy.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Hospital Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.