NCT Number: NCT04783701
The purpose of this study is to compare the presence of graft patency in single aspirin vs dual anti platelet therapy (DAPT) treatment including ticagrelor in patients with acute coronary syndrome (ACS) treated with coronary artery bypass surgery (CABG). Follow up time is 12-36 months postoperatively and the patency will be evaluated with coronary computed tomography angiography (CCTA)
Interested in participating?
Request Info18 year and older
All sexes
Observational
Department of Heart Disease, Haukeland University Hospital, Bergen, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12-36 months
Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or invasive coronary angio (ICA) since CABG, intention to treat (ITT) analysis.
Time frame: 12-36 months
Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, per protocol (PP) analysis.
Time frame: 12-36 months
Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, ITT analysis.
Time frame: 12-36 months
Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, PP analysis.
Time frame: 12-36 months
Defined as patency on CCTA (FitzGibbon A) without graft failure identified on CCTA and/or ICA since CABG, patients on oral anticoagulants excluded, ITT (sensitivity analysis).
Time frame: 12-36 months
Defined as non-occlusion on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, patients on oral anticoagulants excluded, PP (sensitivity analysis).
Time frame: 12-36 months
Possible interactions in response to study treatment, with special focus on the following factors; age, gender, renal function, diabetes, oral anticoagulant therapy, adherence to study treatment and time from end of study medication.
Time frame: 12-36 months
Performed on the graft patency of internal mammary artery (IMA) in the two treatment groups, as well as if there are any differences in graft patency between different anastomoses and grafting techniques.
Possible predictors of graft failure in general, with age, gender, diabetes, obesity, renal failure, urgency level and length of surgery, per-operative complications, number and type of graft as well as pre-operative fractional flow reserve as variables to explore.
Gender analysis will be performed, analyzing if female gender is associated with worse prognosis post CABG, adjusting for their higher age and burden of co-morbidities.
Contact information is provided by the study sponsor or research team.
Jonas Holm, MD, PhD
CONTACT
Sofia Sederholm Lawesson, MD, PhD
CONTACT
University Hospital, Linkoeping
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07258290
Acute Coronary Syndrome, Angina Pectoris
Washington D.C., District of Columbia, United States
View Trial DetailsNCT07032389
Acute Coronary Syndrome, Cardiovascular Diseases
Dallas, Texas, United States
View Trial DetailsNCT06332859
Acute Coronary Syndrome, Cardiomyopathies
Bad Tatzmannsdorf, Burgenland, Austria
View Trial DetailsNCT01311323
Acute Coronary Syndrome, Cardiovascular Diseases
Chrzanów, Malopolska, Poland
View Trial Details