Preclinical antiplatelet treatment with Cangrelor in patients presenting with ST-Elevation myocardial infarction: a randomized, double-blind, placebo-controlled pilot trial

INTERVENTION: 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 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0,2‐ Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use CONDITION: ST‐Elevation Myocardial Infarction Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: This study tries to find an improved treatment concept of preclinical antiplatelet treatment 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) 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. Timepoint(s) of evaluation of this end point: admission to the emergency department ; hospital follow‐up SECONDARY OUTCOME: 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 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 < 120 min • pretreatment with morphine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32