Pharmacodynamic comparison of different oral P2Y12-receptor inhibitor loading strategies for transitioning from cangrelor in patients undergoing coronary stenting
Phase 3
Completed
- Conditions
- I25Chronic ischaemic heart disease
- Registration Number
- DRKS00009739
- Lead Sponsor
- niversitäts-Herzzentrum Freiburg - Bad Krozingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Hemodynamically stable patients with obstructive coronary heart disease and planned coronary stent implantation
- Pretreatment with aspirin
- Men and women over the age of 18 years
- Written informed consent
Exclusion Criteria
- Acute myocardial infarction
- Treatment with P2Y12-receptor inhibitor, fibrinolysis or GPIIb/IIIa inhibitor within 7 days before enrollment
- Contraindication for treatment with aspirin, cangrelor, clopidogrel, ticagrelor or prasugrel according to EMEA label (in particular: Allergy, Active bleeding or high bleeding risk, history of stroke or TIA, severe liver disease)
- Severe thrombocytopenia (<50.000/µl)
- Known severe disorder of the coagulation system
- Pregnancy or lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with ADP-induced platelet aggregation < 468 AU x min (Multiplate-Test, Roche Diagnostics) tested 1 hour after discontinuation of cangrelor.
- Secondary Outcome Measures
Name Time Method - Proportion of patients with ADP-induced platelet aggregation beween 189 and 467 AU x min (Multiplate-Test, Roche Diagnostics) <br>- Analysis of platelet reactivity as continous variable at different time points<br>- Interaction of genetic polymorphisms (e.g. CYP2C19), clinical and laboratory variables with pharmacodynamic effects in the different treatment arms<br>- Ischemic endpoints, bleeding events