A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery.
- Conditions
- bypass surgeryCoronary artery bypass grafting10011082
- Registration Number
- NL-OMON50593
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 499
1) More than 21 years of age, 2) Planned CABG with the use of 1 or more SVGs
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The rate of SVG occlusion as assessed with CCTA at 1 year after randomization</p><br>
- Secondary Outcome Measures
Name Time Method