Efficacy and Safety of cangrelor in adjunct to anticoagulation in patients with myocaRdial infarction related severe acute heart failure needing extracorporeal circulatory support.
Phase 1
- Conditions
- Adult patients treated in VA ECMO for cardiogenic shock/cardiac arrest undergoing PCI.Given the high incidence of bleeding from conventional antithrombotic therapy, the use of readily available and rapidly metabolized cangrelor should result in adequate efficacy and increased safety. Patients will receive scoagulation with bivalirudin (target apt 55-70 seconds) and cangrelor with starting dose 0.125 mcg/kg/min andadjusted with step +/- 0.125 mcg/kg/min.MedDRA version: 20.0Level: LLTClassification code: 10040563Term: Shock cardiogenic Class: 10007541Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-512829-81-00
- Lead Sponsor
- Ospedale San Raffaele S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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 i.v. loading dose or patients naïve to any anti-thrombotic agent.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method