Pharmacodynamic comparison of different oral P2Y12-receptor inhibitor loading strategies for transitioning from cangrelor in patients undergoing coronary stenting

INTERVENTION: Trade Name: Efient Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: PRASUGREL CAS Number: 150322‐43‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Trade Name: Brilique Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: TICAGRELOR Other descriptive name: TICAGRELOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90‐ Trade Name: Plavix Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: CLOPIDOGREL HYDROGEN SULFATE Other descriptive name: CLOPIDOGREL HYDROGEN SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ CONDITION: Patients with obstructive coronary heart disease undergoing percutaneous coronary stent implantation. ; MedDRA version: 18.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 18.1 Level: LLT Classification code 10069038 Term: Bare metal coronary stent placement System Organ Class: 100000004865 ; MedDRA version: 18.1 Level: LLT Classification code 10069037 Term: Drug‐eluting coronary stent placement System Organ Class: 100000004865 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Randomized comparison of the pharmacodynamic effectiveness of; different loading regimes with P2Y12 receptor antagonists for transitioning from cangrelor given either together with cangrelor immediately before coronary intervention (prasugrel 60mg, ticagrelor 180mg) or immediately after discontinuation of cangrelor (clopidogrel 600mg). Primary endpoint is the proportion of; patients with a platelet aggregation of less than 468 AU x min; (Multiplate Test, Roche Diagnostics) tested 1 hours after discontinuation of cangrelor. Primary end point(s): Proportion of patients with ADP‐induced platelet function less than 468; AU x min (Multiplate Test, Roche Diagnostics). Secondary Objective: Evaluation of further platelet function parameters and timepoints.; Evaluation of clinical safety endpoints of the different loading regimes; with P2Y12 receptor antagonists. Timepoint(s) of evaluation of this end point: 1 hour after discontinuation of cangrelor. Additional analyses for 0.5, 1.5, 2 hours and day 1 after discontinuation of cangrelor. SECONDARY OUTCOME: Secondary end point(s): Evaluation of further platelet function parameters and timepoints.; Incidence of ischemic (death, non‐fatal myocardial infarction, urgent coronary revascularization, stroke) and bleeding endpoints (BARC criteria).; Impact of genetic and clinical variables on the pharmacodynamic; response to different loading regimes. Timepoint(s) of evaluation of this end point: Bleeding and ischemic endpoints: up to 30 days following enrollment.; Pharmacodynamic response: 0, 0.5, 1.0, 1.5, 2.0 hours and day 1 after discontinuation of cangrelor. INCLUSION CRITERIA: Hemodynamically stable patients with obstructive coronary heart disease and planned coronary stent implantation. Pretreatment with aspirin (=100mg daily or loading dose of 400mg before coronary angiography). Age = 18 years. Written informed consent. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50