The primary objective of this study ist to test the hypothesis that ticagrelor is superior to Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in patients undergoing artery bypass operation. The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial infarction, recurent revascularisation, and stroke at twelve month after coronary artery bypass operation.
For stable patients who underwent coronary bypass operation, Aspirin alone currently represents the gold standard of antiplatelet treatment. The CABG substudy of the PLATO-trial (http://www.nejm.org/doi/full/10.1056/NEJMoa0904327) comprising more than 1200 patients has convincingly shown a high significant reduction of cardiovascular and all-cause mortality for patients recieving Aspirin and Ticagrelor as compared to those subjects randomized to Aspirin plus Clopidogrel. Moreover the results of the PLATO CABG substudy showed that benefits of Ticagrelor increase with decreasing Aspirin doses. Therefore Ticagrelor monotherapy (2x 90mg/day) appears to offer the best balance of safety with anticipated improved efficacy over Aspirin (1x 100mg/day) alone, but until now there are no further data available to support this hypothesis. Hence this study (TiCAB) is assigned as a pivotal efficacy and safety study of Ticagrelor in patients undergoing coronary artery bypass operation and to test the hypothesis that ticagrelor is superior to Aspirin for the prevention of major cardio- and cerebrovascular events (MACCE) in this patient population. The TiCAB trial is designed as a randomized, double-blind, double-dummy, parallel group, phase III, multicenter study, comparing the efficacy and safety of Ticagrelor 90mg administered twice daily with Aspirin 100mg once daily, for the prevention of MACCE within the first year after CABG operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
MACCE
Composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke
Time frame: at 12 months after coronary artery bypass surgery
Cardiovascular death
Time frame: at 12 months after coronary artery bypass surgery
Major bleeding events
Incidence of major bleeding events
Time frame: within 12 months after coronary arerty bypass surgery
All cause death
All cause death
Time frame: at 12 months after coronary artery bypass surgery
Myocardial Infarction
Time frame: at 12 months after coronary artery bypass surgery
Target Lesion Revascularization
Time frame: at 12 months after coronary artery bypass surgery
Stroke
Time frame: at 12 months after coronary artery bypass surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1,893
Placebo
Medizinische Universität Wien
Vienna, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
Deutsches Herzzentrum München
Munich, Bavaria, Germany
Herzzentrum Brandenburg in Bernau
Bernau bei Berlin, Brandenburg, Germany
Herz- und Kreislaufzentrum Rothenburg an der Fulda
Rotenburg an der Fulda, Hesse, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Universitätsklinikum Aachen
Aachen, Germany
Herz- und Gefäßzentrum
Bad Bevensen, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
...and 19 more locations