ST-elevation myocardial infarction, cardiac arrest
Conditions
Interventions
Trade Name: Kengrexal
Product Name: Kengrexal
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: CANGRELOR
CAS Number: 163706-06-7
Current Sponsor cod
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-74 years • Comatose survivors of OHCA • Estimated interval of =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Pregnant or breast-feeding patients • Body weight <60kg • Response to verbal commands after ROSC (thus not eligible for TTM) • Cardiac arrest due to trauma, exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning, or intracranial hemorrhage • Patients not achieving ROSC or subjected to an extracorporeal circulatory assist device • Acute treatment with P2Y12r inhibitor other than prasugrel or ticagrelor • Active bleeding or increased risk of bleeding because of irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension • Known history of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) • Known history of severe hepatic impairment (Child Pugh C) • Known history of severe renal impairment (creatinine clearance <30mL/min) • Hypersensitivity to the active substance or to any of the excipients • Terminal illness present before cardiac arrest • Thrombolysis therapy • Scheduled for coronary bypass surgery (CABG) • Prior P2Y12r inhibitor use in the past 7 days • Prior vitamin K antagonists/NOACs use in past 7 days • Patients with known allergic reaction to P2Y12r inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the additive platelet suppressing effect of iv P2Y12r inhibitor cangrelor in cardiac arrest patients with STEMI. In particular, the trial aims to investigate whether the additional iv infusion of cangrelor (as “on top treatment”) is superior (i.e. stronger and faster) to the standard oral P2Y12r inhibitor regimen in terms of suppressing ADP-dependent platelet activation at the time of cardiac intervention (i.e. stent placement) in out-of-hospital cardiac arrest (OHCA) patients with STEMI treated with therapeutic hypothermia (TH).;Secondary Objective: Pharmacokinetic profile of cangrelor, prasugrel and ticagrelor in cardiac arrest patients wit STEMI treated with therapeutic hypothermia Cangrelor safety ;Primary end point(s): Platelet reactivity at the time of cardiac intervention (i.e. at the time of stent placement) measured by impedance aggregometry (Multiplate Analyzer, aggregation units/min, AU*min).;Timepoint(s) of evaluation of this end point: at baseline, at the time of stent placement, 15minutes, 30minutes, 60minutes, 120minutes, 240minutes, 360minutes, 12hours and 24hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Platelet reactivity (ADP-dependent platelet inhibition) at baseline, at the time of stent placement, 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes and 12 hours after study drug administration (Multiplate Analyzer, VASP assay, PFA-100). Onset of ADP-dependent platelet inhibition (Multiplate Analyzer, VASP assay, PFA-100). 15 minutes and 30 minutes time points were chosen to exactly identify the onset of ADP-dependent platelet inhibition. Pharmacokinetic profile of cangrelor, prasugrel and ticagrelor at the time of stent placement, 15 minutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes and 12 hours after study drug administration. Adverse events (minor and major bleeding, early definite stent thrombosis, stroke, revascularization procedure with PCI or coronary artery bypass grafting), ED/ICU mortality, laboratory safety parameters (CBC, chemistry including troponin, coagulation), time course of TTM (esophageal und urinary bladder temperature);Timepoint(s) of evaluation of this end point: at baseline, at the time of stent placement, 15minutes, 30minutes, 60minutes, 120minutes, 240minutes, 360minutes, 12hours and 24hours | — |
Countries
Austria
Contacts
Public ContactDepartment of Emergency Medicine
Medical University of Vienna
Outcome results
None listed