Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02352402
Eligibility Criteria:
Inclusion Criteria:
* More than 21 years of age
* Planned coronary artery bypass grafting (CABG) with the use of 1 or more saphenous vein grafts, CABG being an isolated procedure or part of a combined aortic valce replacement surgery with bioprothesis.
Exclusion Criteria:
* Unable to give informed consent or a life expectancy of less than 1 year
* Concomitant valve, aorta or rhythm surgery during the same session, (excluding aortic bioprothesis)
* Inability to undergo coronary computed tomography angiography, in the investigator's opinion, for instance due to severe claustrophobia or contrast allergy
* Use of oral anticoagulants (acenocoumarol, phenprocoumon, dabigatran, rivaroxaban, etc) 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
* 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
* Use of antiplatelet drugs other than aspirin (clopidogrel, prasugrel, ticagrelor, dipyridamol, etc.) and a contraindication for discontinuation of this medication after CABG, according to the treating physician or the investigator
* Women who are known to be pregnant, who have given birth within the past 90 days or who are breastfeeding
* Pre-menopausal women without adequate contraception
* Severe renal function impairment requiring dialysis
* Moderate or severe hepatic impairment
* Active malignancy with increase in bleeding risk, in the investigator's opinion
* Use of strong inhibitors of CYP3A4 (e.g. ketaconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
* Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion
* Contraindication for the use of ticagrelor or aspirin (i.e. history of intracranial bleeding, high bleeding risk, previous allergic reaction), in the investigator's opinion
* Previous inclusion in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02352402
Study Brief:
Protocol Section:
NCT02352402