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Am Heart J. 2016 Sep;179:69-76. doi: 10.1016/j.ahj.2016.05.017. Epub 2016 Jun 18.

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: Rationale and design of the Ticagrelor in CABG (TiCAB) trial: An Investigator-Initiated trial.

Author information

1
German Heart Center Munich, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), and partner site Munich Heart Alliance, Munich, Germany. Electronic address: dewaha@dhm.mhn.de.
2
Department of Cardiac Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.
3
German Heart Center Munich, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), and partner site Munich Heart Alliance, Munich, Germany.
4
Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Germany.
5
Department of Cardiac Surgery, Klinikum Links der Weser, Bremen, Germany.
6
Department of Cardiology and Angiology, Klinikum Links der Weser, Bremen, Germany.
7
Department of Thoracic and Cardiovascular Surgery, Georg-August-University Goettingen, Goettingen, Germany.
8
Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Germany.
9
Department of Cardiac Surgery, Asklepios Klinik St. Georg/Cardioclinic Harburg, Hamburg, Germany.
10
Institute of Physiology, Justus-Liebig University, Giessen, Germany.
11
Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany.
12
Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Germany.
13
Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Germany; DZHK (German Center for Cardiovascular research)-partner side Berlin.
14
Department of Cardiovascular Surgery, Heart Center Freiburg University, Freiburg, Germany.
15
Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.
16
Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
17
Department of Cardiac and Thoracic Vascular Surgery, University of Lübeck, Lübeck, Germany.
18
Medical Clinic II, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
19
Department of Cardiology, Kerckhoff Heart and Thorax Center, Germany Justus Liebig University of Giessen, Department of Internal Medicine I, Gießen, Germany.
20
Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen am Rhein, Germany.
21
Klinik für Innere Medizin, Schön Klinik Neustadt, Neustadt i.H., Germany.
22
Department of Cardiovascular Surgery, German Heart Center Munich, Germany.

Abstract

BACKGROUND:

For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial. Ticagrelor, an oral, reversibly binding and direct-acting P2Y12 receptor antagonist, provides a rapid, competent, and consistent platelet inhibition and has shown beneficial results compared with clopidogrel in the subset of patients undergoing bypass surgery in a large previous trial.

HYPOTHESIS:

Ticagrelor is superior to ASA for the prevention of major cardiovascular events within 1 year after CABG.

STUDY DESIGN:

The TiCAB trial (NCT01755520) is a multicenter, phase III, double-blind, double-dummy, randomized trial comparing ticagrelor with ASA for the prevention of major cardiovascular events within 12 months after CABG. Patients undergoing CABG will be randomized in a 1:1 fashion to either ticagrelor 90 mg twice daily or ASA 100 mg once daily. The study medication will be started within 24 hours after surgery and maintained for 12 months. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, and repeat revascularization at 12 months after CABG. The sample size is based on an expected event rate of 13% of the primary end point within the first 12 months after randomization in the control group, a 2-sided α level of .0492 (to preserve the overall significance level of .05 after planned interim analysis), a power of 0.80%, 2-sided testing, and an expected relative risk of 0.775 in the active group compared with the control group and a dropout rate of 2%. According to power calculations based on a superiority design for ticagrelor, it is estimated that 3,850 patients should be enrolled.

SUMMARY:

There is clinical equipoise on the issue of optimal platelet inhibition after CABG. The TiCAB trial will provide a pivotal comparison of the efficacy and safety of ticagrelor compared with ASA after CABG.

PMID:
27595681
DOI:
10.1016/j.ahj.2016.05.017
[Indexed for MEDLINE]

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