Coronary Artery Disease Clinical Trial
Official title:
A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared With Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft Operation TiCAB- Ticagrelor in CABG
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.
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