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 Cl
Conditions
Interventions
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
Sponsors
University Heart Center Freiburg - Bad Krozingen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Acute myocardial infarction Treatment with P2Y12-receptor inhibitor, fibrinolysis, or GP IIb/IIIa inhibitor within 7 days before enrollment. Contraindication for treatment with aspirin, cangrelor, clopidogrel, ticagrelor or prasugrel according to EMEA label (in particular: active bleeding, history of stroke or TIA). Current oral anticoagulation. Severe thrombocytopenia (< 50.000/µl). Known severe disorder of the coagulation system. Pregnancy or lactation. Dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: Evaluation of further platelet function parameters and timepoints. Evaluation of clinical safety endpoints of the different loading regimes with P2Y12 receptor antagonists.;Primary end point(s): Proportion of patients with ADP-induced platelet function less than 468 AU x min (Multiplate Test, Roche Diagnostics).;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactStudy Group PD Dr. Hochholzer
University Heart Center Freiburg - Bad Krozingen, Department of Cardiology and Angiology II
Outcome results
None listed