The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery

• Status: Active, not recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous vein graft occlusion as assessed with coronary computed tomography angiography at 1 year after coronary artery bypass grafting surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: J.M. ten Berg
• Collaborator: AstraZeneca
• Treatments: Ticagrelor

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