ST-Elevation Myocardial Infarction
Conditions
Interventions
Trade Name: Kengrexal
Product Name: Cangrelor
Product Code: Cangrelor
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: CANGRELOR
CAS Number: 163706-06-7
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with out-of-hospital ST-elevation myocardial infarction • male or non-pregnant female, aged between 18 and 74 • hemodynamically stable, Killip class I • planned to undergo primary percutaneous coronary intervention (PCI) • PCI available =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: • bodyweight 99kg • known intolerance or allergy to cangrelor or another P2Y12 receptor inhibitor • active bleeding or increased risk of bleeding because of known coagulation or platelet disorders • previous hemorrhagic stroke, under oral anticoagulant therapy, moderate to severe liver disease • pregnancy or active breastfeeding • intake of clopidogrel, prasugrel or ticagrelor in the past 14 days • patient in a palliative setting OR life expectancy < 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study tries to find an improved treatment concept of preclinical antiplatelet treatment in the acute setting of ST-elevation myocardial infarction.;Secondary Objective: Further, this study evaluates the safety, efficacy and feasibility of preclinical antiplatelet treatment with cangrelor in the acute setting of ST-elevation myocardial infarction.;Primary end point(s): The rate of HTPR at the time of emergency department admission defined as ADP-induced platelet activation > 46 U (measured by MEA analysis) in the intervention group vs. the placebo group. Primary safety outcome: major bleeding at 30 days according to the TIMI and BARC (3-5) bleeding definition Primary safety endpoint: in-hospital major bleeding according to the TIMI and BARC (3-5) bleeding definition (1);Timepoint(s) of evaluation of this end point: admission to the emergency department hospital follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The rate of HTPR (ADP-induced platelet activation > 46 U measured by MEA analysis) at PCI, 1h after cessation of cangrelor and 6h after the ticagrelor LD in the intervention group vs. the placebo group - Closure time (CT) tested with the PFA-100 P2Y test and platelet reactivity index (PRI) tested with the VASP-P assay at ED arrival, at PCI, 1h after cessation of cangrelor and 6h after the ticagrelor LD in the intervention group vs. the placebo group - Resolution of ST-segment elevation before PCI - Resolution of ST-segment elevation at 60 min after PCI - TIMI flow grade 3 after procedure - Composite of cardiovascular death, myocardial infarction, stroke at 7 days and 30 days - urgent revascularization at 7 days and 30 days - stent thrombosis at 7 days and 30 days - major bleeding at 7 days and 30 days according to the TIMI and BARC (3-5) bleeding definition (1) - in-hospital adverse events (MACE, stent thrombosis, all-cause mortality) - 7-day, 30-day mortality;Timepoint(s) of evaluation of this end point: admission to the emergency department PCI 60 minutes after PCI 1 hour after cessation of cangrelor infusion 6 hours after ticagrelor loading dose 7-day follow-up 30-day follow-up | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed