bypass surgery Coronary artery bypass grafting
Conditions
Interventions
Patients will be randomly assigned to treatment with 90mg of ticagrelor or a
matching placebo twice daily in addition to standard treatment with ASA for the
duration of 1 year. Patients will be pres
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) More than 21 years of age, 2) Planned CABG with the use of 1 or more SVGs
Exclusion criteria
Exclusion criteria: 1) Unable to give informed consent or a life expectancy of less than 1 year, 2) Concomitant valve (excluding aortic bioprothesis), aorta or rhythm surgery during the same session, 3) Inability to undergo CCTA, in the investigator*s opinion, for instance due to severe claustrophobia or contrast allergy, 4) Use of oral anticoagulants (acenocoumarol, fenprocoumon, NOACs) and a contraindication for discontinuation of this medication or the expectation that the patient will have an indication for the use of these drugs after surgery , 5) Placement of a drug-eluting stent in a coronary or cerebral artery within 6 months of CABG or placement of a bare-metal stent in a coronary or cerebral artery within 1 month of CABG , 6) Use of other antiplatelet drugs than ASA (clopidogrel, prasugrel, ticagrelor, dypiridamol, etc.) and a contraindication for discontinuation of this medication after CABG, according to the treating physician or the investigator, 7) Women who are known to be pregnant, who have given birth within the past 90 days or who are breastfeeding, 8) Pre-menopausal women without adequate contraception, 9) Severe renal function impairment requiring dialysis , 10) Moderate or severe hepatic impairment, 11) Active malignancy with increase in bleeding risk, in the investigator*s opinion, 12) Use of strong inhibitors of CYP3A4 (e.g. ketaconazole, claritromycin, nefazodone, ritonavir, atazanavir), 13) Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator*s opinion., 14) Contraindication for the use of ticagrelor or ASA (i.e. history of intracranial bleeding, high bleeding risk, previous allergic reaction), in the investigator*s opinion, 15) Previous randomization in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of SVG occlusion as assessed with CCTA at 1 year after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| • SVG failure at 1 year after randomization. • significant SVG stenosis, arterial graft occlusion, and significant arterial graft stenosis as assessed with CCTA at 1 year after randomization, and combinations of these endpoints • Bleeding Academic Research Consortium (BARC) minor (type 1 or 2) and major (type 3, 4 or 5) bleeding at 30 days and 1 year after randomization • TIMI minimal minor and major bleeding at 30 days and 1 year after randomization • PLATO minimal minor and major bleeding at 30 days and 1 year after randomization • the level of platelet reactivity, as assessed with platelet function tests pre-operative and 3 days and 1 year after randomization (substudy) • high platelet reactivity, as assessed with platelet function tests pre-operative and 3 days and 1 year after randomization (substudy) • the level of GDF-15 as assessed pre-operatively and 3 days and 1 year after randomization (substudy) | — |
Countries
Netherlands
Outcome results
None listed